FDA 510(k) Application Details - K960045

Device Classification Name Drape, Surgical

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510(K) Number K960045
Device Name Drape, Surgical
Applicant THE SEWING SOURCE, INC.
802 EAST NASH ST.
P.O. BOX 639
SPRING HOPE, NC 27882 US
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Contact JANET SLOAD
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 01/02/1996
Decision Date 06/05/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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