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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Cast Removal, Ac-Powered
510(k) Number K932653
Device Name SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
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 Number888.5960
Classification Product Code
LGH  
Date Received06/02/1993
Decision Date 01/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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