FDA 510(k) Application Details - K010951

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K010951
Device Name Dressing, Wound And Burn, Occlusive
Applicant ISLAND DRESSING, LLC.
300 CORPORATE PKWY.
SUITE 116N
AMHERST, NY 14226 US
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Contact JOHN A DOBOS
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 03/28/2001
Decision Date 06/11/2001
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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