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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 K963547
Device Name THE WRAP IMMOBILIZATION SYSTEM
Applicant
Safe Restraints, Inc.
1500 Newell Ave.
#408
Walnut Creek,  CA  94596
Applicant Contact MARK RYCHLIK
Correspondent
Safe Restraints, Inc.
1500 Newell Ave.
#408
Walnut Creek,  CA  94596
Correspondent Contact MARK RYCHLIK
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/05/1996
Decision Date 12/02/1996
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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