DRAINAGE BAG

Bag, Bile Collecting

REMINGTON MEDICAL, INC.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Drainage Bag.

Pre-market Notification Details

Device IDK990428
510k NumberK990428
Device Name:DRAINAGE BAG
ClassificationBag, Bile Collecting
Applicant REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta,  GA  30005
ContactSteve Woody
CorrespondentSteve Woody
REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta,  GA  30005
Product CodeEXF  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-11
Decision Date1999-08-12

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