FDA 510(k) Application Details - K020318

Device Classification Name Dressing, Wound, Drug

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510(K) Number K020318
Device Name Dressing, Wound, Drug
Applicant SCIVOLUTIONS, INC
962 ALLEGRO LN.
APOLLO BEACH, FL 33572 US
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Contact ART WARD
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 01/30/2002
Decision Date 02/03/2003
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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