FDA 510(k) Application Details - K963435

Device Classification Name Restraint, Protective

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510(K) Number K963435
Device Name Restraint, Protective
Applicant ZIMMER PATIENT CARE DIVISION
200 WEST OHIO AVE.
P.O.BOX 10
DOVER, OH 44622 US
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Contact PAUL OSORIO
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Regulation Number 880.6760

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Classification Product Code FMQ
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Date Received 08/30/1996
Decision Date 11/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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