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FDA 510(k) Application Details - K020308
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
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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JOYCE NING
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Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
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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