CARAPACE INCISION AND DRAINAGE TRAYS

Suture Removal Kit

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Incision And Drainage Trays.

Pre-market Notification Details

Device IDK931597
510k NumberK931597
Device Name:CARAPACE INCISION AND DRAINAGE TRAYS
ClassificationSuture Removal Kit
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 CodeMCZ  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-01
Decision Date1993-11-05

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