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FDA 510(k) Application Details - K982613
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K982613
Device Name
Surgeon'S Gloves
Applicant
OMNIGRACE (THAILAND) LTD.
641 MOO 5 KANCHANAWANIT RD.
TAMBON BANPRU
HATYAI, SONGKHLA 90250 TH
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Contact
WILLIAM E PATTON
Other 510(k) Applications for this Contact
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
07/27/1998
Decision Date
09/02/1998
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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