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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 K971742
Device Name DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact ARLENE C SAULL
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent Contact ARLENE C SAULL
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received05/12/1997
Decision Date 07/24/1997
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
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