SOFT TISSUE SUTURE WASHER/3 HOLE WASHER

Washer, Bolt Nut

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Soft Tissue Suture Washer/3 Hole Washer.

Pre-market Notification Details

Device IDK910229
510k NumberK910229
Device Name:SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
ClassificationWasher, Bolt Nut
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactDavid A Kotkovetz
CorrespondentDavid A Kotkovetz
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-18
Decision Date1991-07-24

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