FDA 510(k) Application Details - K961699

Device Classification Name Cover, Barrier, Protective

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510(K) Number K961699
Device Name Cover, Barrier, Protective
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JANET JOHNSON
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Regulation Number 878.4370

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Classification Product Code MMP
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Date Received 05/02/1996
Decision Date 08/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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