FDA 510(k) Application Details - K020308

Device Classification Name Surgeon'S Gloves

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510(K) Number K020308
Device Name Surgeon'S Gloves
Applicant SSL AMERICA'S, INC.
3585 ENGINEERING DR.,SUITE 200
P.O. BOX 926090
NORCROSS, GA 30092-9214 US
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Contact JOYCE NING
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 01/29/2002
Decision Date 04/03/2002
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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