FDA 510(k) Application Details - K103793

Device Classification Name Dressing, Wound, Drug

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510(K) Number K103793
Device Name Dressing, Wound, Drug
Applicant Smith & Nephew, Inc
970 LAKE CARILLON DRIVE,
SUITE 110
ST. PETERSBURG, FL 33716 US
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Contact TERRY MCMAHON
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 12/27/2010
Decision Date 05/02/2011
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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