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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963453
Device Name CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
Applicant
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
P.O. Box 56
Grand Blanc,  MI  48439
Applicant Contact MICHAEL CZOP
Correspondent
Contour Fabricators, Inc.
4100 E. Baldwin Ave.
P.O. Box 56
Grand Blanc,  MI  48439
Correspondent Contact MICHAEL CZOP
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/15/1996
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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