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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 K963436
Device Name RESTRAINT ACCESSORIES
Applicant
J. T. Posey Co.
5635 Peck Rd.
Arcadia,  CA  91006
Applicant Contact MICHAEL KEEFE
Correspondent
J. T. Posey Co.
5635 Peck Rd.
Arcadia,  CA  91006
Correspondent Contact MICHAEL KEEFE
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received08/30/1996
Decision Date 11/22/1996
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
Recalls CDRH Recalls
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