FDA 510(k) Application Details - K981713

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K981713
Device Name Dressing, Wound And Burn, Occlusive
Applicant SMITH & NEPHEW, INC.
11775 STARKEY RD.
LARGO, FL 33773-4727 US
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Contact JIM G IRVIN
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 05/15/1998
Decision Date 07/31/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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