FDA 510(k) Application Details - K002666

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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510(K) Number K002666
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant MEDI-TECH INTL. CORP.
26 COURT ST.
BROOKLYN, NY 11242 US
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Contact HERBERT A PERRY
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Regulation Number 000.0000

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Classification Product Code MGQ
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Date Received 08/25/2000
Decision Date 02/27/2001
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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