DERMACARE TIE HOLDER

Retention Device, Suture

DERMACARE

The following data is part of a premarket notification filed by Dermacare with the FDA for Dermacare Tie Holder.

Pre-market Notification Details

Device IDK893995
510k NumberK893995
Device Name:DERMACARE TIE HOLDER
ClassificationRetention Device, Suture
Applicant DERMACARE 7651 NATIONAL TURNPIKE Louisville,  KY  40214
ContactRyan Sell
CorrespondentRyan Sell
DERMACARE 7651 NATIONAL TURNPIKE Louisville,  KY  40214
Product CodeKGS  
CFR Regulation Number878.4930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-05
Decision Date1989-08-11

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