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FDA 510(k) Application Details - K053495
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K053495
Device Name
Drape, Surgical
Applicant
ADVANCE MEDICAL DESIGNS, INC.
1241 ATLANTA INDUSTRIAL DR.
MARIETTA, GA 30066 US
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Contact
WILLIAM SLEVIN
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2005
Decision Date
03/16/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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