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FDA 510(k) Application Details - K061491
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K061491
Device Name
Gown, Surgical
Applicant
LAC MAC, LTD.
P.O. BOX 92493
AUSTIN, TX 78709 US
Other 510(k) Applications for this Company
Contact
JEFFREY 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
05/31/2006
Decision Date
08/09/2006
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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