FDA 510(k) Application Details - K001239

Device Classification Name Surgeon'S Gloves

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510(K) Number K001239
Device Name Surgeon'S Gloves
Applicant ANSELL PERRY
1875 HARSH AVE. S.E.
MASSILLON, OH 44646-7199 US
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Contact JAMES R CHATTERTON
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 04/18/2000
Decision Date 05/15/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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