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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K931819
Device Name CARAPACE SUTURE REMOVAL 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 Number890.5975
Classification Product Code
IRO  
Date Received04/08/1993
Decision Date 01/26/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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