Reference Source

HSIN TEN ENTERPRISES MEXICO · 89-08 · MEXICO

For HSIN TEN ENTERPRISES MEXICO · 89-08 · MEXICO, import alert is 89-08; 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)"; country is MEXICO; product is Acupuntador; product code is 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 08/30/2013; address is Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO, verified against its source on 2026-09-16.

Firm
HSIN TEN ENTERPRISES MEXICO 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
MEXICO verified
Address
Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO verified
Date published
08/30/2013 verified
Product code
89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy verified
Product
Acupuntador verified
FDA notes
class II; 8/30/2013 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

HSIN TEN ENTERPRISES MEXICO Date Published : 08/30/2013 Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 04/23/2021 Desc: Acupuntador Notes: class II; 8/30/2013

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

Source

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