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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 K901677
Device Name CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER
Applicant
Buckman Co., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Buckman Co., Inc.
1000 Burnett Ave., Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.5960
Classification Product Code
LGH  
Date Received04/10/1990
Decision Date 04/23/1990
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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