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FDA 510(k) Application Details - K974783
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K974783
Device Name
Surgeon'S Gloves
Applicant
ANSELL PERRY
1875 HARSH AVE. S.E.
MASSILLON, OH 44646-7199 US
Other 510(k) Applications for this Company
Contact
JAMES R CHATTERTON
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
12/22/1997
Decision Date
02/09/1998
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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