BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

PFIZER HOSPITAL PRODUCTS GROUP, INC.

The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Bondek Polyglycolic Acid Synthetic Absorb. Suture.

Pre-market Notification Details

Device IDK905482
510k NumberK905482
Device Name:BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River,  MA  02722
ContactMichael Santalucia
CorrespondentMichael Santalucia
PFIZER HOSPITAL PRODUCTS GROUP, INC. 600 AIRPORT RD. Fall River,  MA  02722
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-06
Decision Date1991-03-14

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