SMF RESORBABLE MESHES AND SHEETS

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Smf Resorbable Meshes And Sheets.

Pre-market Notification Details

Device IDK003786
510k NumberK003786
Device Name:SMF RESORBABLE MESHES AND SHEETS
ClassificationPlate, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-08
Decision Date2001-02-27

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