FDA 510(k) Application Details - K043587

Device Classification Name Dressing, Wound, Drug

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510(K) Number K043587
Device Name Dressing, Wound, Drug
Applicant PATRICK D. MCGRATH PH.D
1471 GREYSTONE DRIVE
GURNEE, IL 60031 US
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Contact PATRICK D MCGRATH
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 12/28/2004
Decision Date 02/03/2006
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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