COPOLYESTER FILM DRESSING

Dressing, Wound, Collagen

TRI-STATE HOSPITAL SUPPLY CORP.

The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Copolyester Film Dressing.

Pre-market Notification Details

Device IDK893647
510k NumberK893647
Device Name:COPOLYESTER FILM DRESSING
ClassificationDressing, Wound, Collagen
Applicant TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell,  MI  48843
ContactGeorge J Pluta
CorrespondentGeorge J Pluta
TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell,  MI  48843
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-15
Decision Date1989-10-16

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