FDA 510(k) Application Details - K973699

Device Classification Name Surgeon'S Gloves

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510(K) Number K973699
Device Name Surgeon'S Gloves
Applicant JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON, TX 76004-0130 US
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Contact MAGARET MARSH
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 09/29/1997
Decision Date 12/16/1997
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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