Reference Source

Consultative & Commercial Center " INVET" · 89-08 · UKRAINE

For Consultative & Commercial Center " INVET", import alert is 89-08; country is UKRAINE; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Laser Vision Glasses (Pinhole glasses) | Laser Vision Glasses (Pinhole glasses); product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle | 89 I - - PF Stimulator, Muscle, Powered; date published is 09/16/2009; address is Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE, verified against its source on 2026-09-30.

Firm
Consultative & Commercial Center " INVET" verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
UKRAINE verified
Address
Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE verified
Date published
09/16/2009 verified
Product code
86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle | 89 I - - PF Stimulator, Muscle, Powered each item verified
Product
Laser Vision Glasses (Pinhole glasses) | Laser Vision Glasses (Pinhole glasses) each item verified
FDA notes
02/6/08 | 02/6/08 | ENART a Tens Device 2/6/2008 Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Consultative & Commercial Center " INVET" Date Published : 09/16/2009 Zabolotnoho vul. 35/37 , Odesa, Odeska UKRAINE

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 05/03/2021 Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08 86 H - - QZ Frame, Spectacle Date Published: 05/03/2021 Desc: Laser Vision Glasses (Pinhole glasses) Notes: 02/6/08 89 I - - PF Stimulator, Muscle, Powered Date Published: 09/16/2009 Notes: ENART a Tens Device 2/6/2008 Claims related to disorders of the Central Nervous System; the Peripheral Nervous Systm; the Respiratory system; ect. as well as dental diseases

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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