FDA 510(k) Application Details - K070581

Device Classification Name Dressing, Wound, Drug

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510(K) Number K070581
Device Name Dressing, Wound, Drug
Applicant ADVANCED MEDICAL SOLUTIONS LIMITED
ROAD THREE
WINSFORD INDUSTRIAL ESTATE
WINSFORD, CHESHIRE CW7 3PD GB
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Contact GRAHAME SOMERVILLE
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 03/01/2007
Decision Date 07/13/2007
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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