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FDA 510(k) Application Details - K013603
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K013603
Device Name
Surgeon'S Gloves
Applicant
ANSELL HEALTHCARE PRODUCTS, INC.
1875 HARSH AVENUE, 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2001
Decision Date
11/13/2001
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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