POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING

Suture, Absorbable, Synthetic, Polyglycolic Acid

TYCO HEALTHCARE GROUP

The following data is part of a premarket notification filed by Tyco Healthcare Group with the FDA for Polysorb* Synthetic Absorbable Suture With Modified Packaging.

Pre-market Notification Details

Device IDK063536
510k NumberK063536
Device Name:POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant TYCO HEALTHCARE GROUP 150 GLOVER AVE. Norwalk,  CT  06856
ContactRobert Zott
CorrespondentRobert Zott
TYCO HEALTHCARE GROUP 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-22
Decision Date2007-01-29
Summary:summary

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