CARAPACE STERILE GAUZE TRAYS

General Surgery Tray

CARAPACE, INC.

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

Pre-market Notification Details

Device IDK931759
510k NumberK931759
Device Name:CARAPACE STERILE GAUZE TRAYS
ClassificationGeneral Surgery Tray
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 CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-08
Decision Date1994-01-25

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