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

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Classification Product Code EFQ
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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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