Reference Source

Appasamy Associates · 89-08 · INDIA

For Appasamy Associates, import alert is 89-08; country is INDIA; 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 Intraocular Lens Guides; Intraocular Lenses | Intraocular Lens Guides; Intraocular Lenses; product code is 86 H - - QL Lens, Intraocular | 86 H - - QL Lens, Intraocular | 86 M - - SS Folders and Injectors, Intraocular Lens (IOL); date published is 09/16/2009; address is 11a , Valluvar Nedum Pathai , Rani Anna Nagar , Arumbakkam, Tamil Nagar INDIA, verified against its source on 2026-09-30.

Firm
Appasamy Associates 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
INDIA verified
Address
11a , Valluvar Nedum Pathai , Rani Anna Nagar , Arumbakkam, Tamil Nagar INDIA verified
Date published
09/16/2009 verified
Product code
86 H - - QL Lens, Intraocular | 86 H - - QL Lens, Intraocular | 86 M - - SS Folders and Injectors, Intraocular Lens (IOL) each item verified
Product
Intraocular Lens Guides; Intraocular Lenses | Intraocular Lens Guides; Intraocular Lenses each item verified
FDA notes
Intraocular Lens | Class III | Class III 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

Appasamy Associates Date Published : 09/16/2009 11a , Valluvar Nedum Pathai , Rani Anna Nagar , Arumbakkam, Tamil Nagar INDIA

— accessdata.fda.gov, retrieved 2026-09-22

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 - - QL Lens, Intraocular Date Published: 09/16/2009 Notes: Intraocular Lens 86 H - - QL Lens, Intraocular Date Published: 05/16/2011 Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III 86 M - - SS Folders and Injectors, Intraocular Lens (IOL) Date Published: 05/16/2011 Desc: Intraocular Lens Guides; Intraocular Lenses Notes: Class III

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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