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FDA 510(k) Application Details - K080723
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K080723
Device Name
Gown, Surgical
Applicant
SRI/SURGICAL EXPRESS, INC.
P.O. BOX 92493
AUSTIN, TX 78709 US
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Contact
JEFFERY O STULL
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2008
Decision Date
11/13/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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