FDA 510(k) Application Details - K972458

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K972458
Device Name Dressing, Wound And Burn, Occlusive
Applicant COURTAULDS FIBERS, INC.
HWY. 43, NORTH
P.O.BOX 141
AXIS, AL 36505 US
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Contact ROBERT FEIL
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Regulation Number 000.0000

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Classification Product Code MGP
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Date Received 07/01/1997
Decision Date 09/19/1997
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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