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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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More FDA Info for this Product Code
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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