MAXON** STERILE, SYNTHETIC, ABSORBABLE 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 Maxon** Sterile, Synthetic, Absorbable Suture.

Pre-market Notification Details

Device IDK990951
510k NumberK990951
Device Name:MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactVictor M Clavelli
CorrespondentVictor M Clavelli
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-22
Decision Date1999-04-01
Summary:summary

NIH GUDID Devices

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