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FDA 510(k) Application Details - K961775
Device Classification Name
Gauze/Sponge, Internal
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510(K) Number
K961775
Device Name
Gauze/Sponge, Internal
Applicant
SMITH & NEPHEW UNITED, INC.
11775 STARKLEY RD.
P.O.BOX 1970
LARGO, FL 34649-1970 US
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Contact
JIM IRVIN
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
EFQ
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More FDA Info for this Product Code
Date Received
05/08/1996
Decision Date
07/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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