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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K883294
Device Name SYNTHETIC CAST TAPE
Applicant
Carapace, Inc.
C/O Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Carapace, Inc.
C/O Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.5940
Classification Product Code
LGF  
Date Received08/04/1988
Decision Date 08/30/1988
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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