FDA 510(k) Application Details - K041846

Device Classification Name Drape, Surgical

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510(K) Number K041846
Device Name Drape, Surgical
Applicant MINRAD, INC.
847 MAIN ST.
BUFFALO, NY 14203 US
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Contact JOHN MCNEIRNEY
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 07/08/2004
Decision Date 08/26/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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