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FDA 510(k) Application Details - K980942
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K980942
Device Name
Surgeon'S Gloves
Applicant
LONDON INTERNATIONAL GROUP, INC.
2926 COLUMBIA HIGHWAY
P.O. BOX 8308
DOTHAM, AL 36303 US
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Contact
NEIL ANDERSON
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
03/12/1998
Decision Date
05/11/1998
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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