COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH

Mesh, Surgical, Polymeric

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 Coated Surgipro(tm) Polypropylene Surgical Mesh.

Pre-market Notification Details

Device IDK915526
510k NumberK915526
Device Name:COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
ClassificationMesh, Surgical, Polymeric
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
ContactSteve Reitzler
CorrespondentSteve Reitzler
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk,  CT  06856
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-10
Decision Date1992-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521101446 K915526 000
10884521101340 K915526 000
20884521101354 K915526 000
20884521101361 K915526 000
20884521101378 K915526 000
20884521101385 K915526 000
20884521101392 K915526 000
10884521101401 K915526 000
10884521101418 K915526 000
20884521101422 K915526 000
20884521101439 K915526 000
10884521101333 K915526 000

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