AN3200 DOUBILET DRAIN

Stents, Drains And Dilators For The Biliary Ducts

H.W. ANDERSEN PRODUCTS, INC.

The following data is part of a premarket notification filed by H.w. Andersen Products, Inc. with the FDA for An3200 Doubilet Drain.

Pre-market Notification Details

Device IDK872458
510k NumberK872458
Device Name:AN3200 DOUBILET DRAIN
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant H.W. ANDERSEN PRODUCTS, INC. 221 SOUTH ST. Oyster Bay,  NY  11771
ContactLauren R Andersen
CorrespondentLauren R Andersen
H.W. ANDERSEN PRODUCTS, INC. 221 SOUTH ST. Oyster Bay,  NY  11771
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-23
Decision Date1987-09-21

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