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FDA 510(k) Application Details - K101350
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K101350
Device Name
Drape, Surgical
Applicant
RADSCAN MEDICAL EQUIPMENT, INC.
23910 N. 19TH AVE BLDG 2 SUITE
PHOENIX, AZ 85085 US
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Contact
ORAN R BROWN
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2010
Decision Date
01/04/2011
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
Y
Expedited Review
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