FDA 510(k) Application Details - K042400

Device Classification Name Dressing, Wound, Drug

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510(K) Number K042400
Device Name Dressing, Wound, Drug
Applicant BELCHER PHARMACEUTICALS, INC.
12393 BELCHER ROAD
SUITE 420
LARGO, FL 33773 US
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Contact KOTHA SEKHARAM
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 09/03/2004
Decision Date 11/24/2004
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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