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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K931626
Device Name CARAPACE STERILE COTTON BALLS
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 Number880.5300
Classification Product Code
FRL  
Date Received04/02/1993
Decision Date 12/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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