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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 K963435
Device Name ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE
Applicant
Zimmer Patient Care Division
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Applicant Contact PAUL OSORIO
Correspondent
Zimmer Patient Care Division
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Correspondent Contact PAUL OSORIO
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received08/30/1996
Decision Date 11/06/1996
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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