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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture Removal Kit
510(k) Number K931597
Device Name CARAPACE INCISION AND DRAINAGE TRAYS
Applicant
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Applicant Contact JERRY W MYERS
Correspondent
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Correspondent Contact JERRY W MYERS
Regulation Number878.4800
Classification Product Code
MCZ  
Date Received04/01/1993
Decision Date 11/05/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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