FDA 510(k) Application Details - K972277

Device Classification Name Surgeon'S Gloves

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510(K) Number K972277
Device Name Surgeon'S Gloves
Applicant HMS SERVICES, INC.
48 ALVIN RD.
WEST MILFORD, NJ 07480 US
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Contact HARSH AGGARWAL
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 06/18/1997
Decision Date 10/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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