CARAPACE DEBRIDEMENT KITS

Wrap, Sterilization

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Debridement Kits.

Pre-market Notification Details

Device IDK931669
510k NumberK931669
Device Name:CARAPACE DEBRIDEMENT KITS
ClassificationWrap, Sterilization
Applicant CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
ContactJerry W Myers
CorrespondentJerry W Myers
CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-06
Decision Date1994-02-07

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