FDA 510(k) Application Details - K962972

Device Classification Name Gauze/Sponge, Internal

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510(K) Number K962972
Device Name Gauze/Sponge, Internal
Applicant ACCUNEX CANADA,INC.
100 EAST 15TH STREET,
SUITE 320
FORT WORTH, TX 76102 US
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Contact RICHARD A HAMER
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Regulation Number 000.0000

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Classification Product Code EFQ
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Date Received 07/31/1996
Decision Date 10/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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