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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 K963490
Device Name PROTECTIVE RESTRAINT - BELTS
Applicant
Smith and Nephew Donjoy, Inc.
2985 Scott St.
Vista,  CA  92083
Applicant Contact DAN W MILLER
Correspondent
Smith and Nephew Donjoy, Inc.
2985 Scott St.
Vista,  CA  92083
Correspondent Contact DAN W MILLER
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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