FDA 510(k) Application Details - K023138

Device Classification Name Dressing, Wound, Drug

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510(K) Number K023138
Device Name Dressing, Wound, Drug
Applicant HYDROFERA, LLC.
322 MAIN ST., SUITE 1101
WILLIMANTIC, CT 06226 US
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Contact HEATHER S BOND
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 09/20/2002
Decision Date 01/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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