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FDA 510(k) Application Details - K953879
Device Classification Name
Cap, Surgical
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510(K) Number
K953879
Device Name
Cap, Surgical
Applicant
AMERICAN THRESHOLD INDUSTRIES, INC.
240 SARDIS RD.
P.O. BOX 1209
ENKA, NC 28728 US
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Contact
GREGORY B SCOTT
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYF
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More FDA Info for this Product Code
Date Received
08/16/1995
Decision Date
01/05/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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