FDA 510(k) Application Details - K982648

Device Classification Name Gauze/Sponge, Internal

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510(K) Number K982648
Device Name Gauze/Sponge, Internal
Applicant CELANESE ACETATE CO.
PO BOX 32414
CHARLOTTE, NC 28232-2414 US
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Contact WILLIAM C THOMAS
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Regulation Number 000.0000

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Classification Product Code EFQ
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Date Received 07/29/1998
Decision Date 09/30/1998
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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