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FDA 510(k) Application Details - K151371
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K151371
Device Name
System, Image Processing, Radiological
Applicant
U.S. ARMY DENTAL COMMAND (DENCOM)
4270 GORGES CIRCLE, SUITS 101, B1070
FORT SAM HOUSTON, TX 78234 US
Other 510(k) Applications for this Company
Contact
WILLIAM K. PORTER
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2015
Decision Date
08/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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