HOLLISTER DRAINAGE POUCH

Bag, Drainage, With Adhesive, Ostomy

HOLLISTER, INC.

The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Drainage Pouch.

Pre-market Notification Details

Device IDK801504
510k NumberK801504
Device Name:HOLLISTER DRAINAGE POUCH
ClassificationBag, Drainage, With Adhesive, Ostomy
Applicant HOLLISTER, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFON  
CFR Regulation Number876.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-27
Decision Date1980-08-12

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