MODIFIED USSC* POLYSORB SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Ussc* Polysorb Suture.

Pre-market Notification Details

Device IDK970863
510k NumberK970863
Device Name:MODIFIED USSC* POLYSORB SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-10
Decision Date1997-05-05
Summary:summary

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