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FDA 510(k) Application Details - K163050
Device Classification Name
Media,Coupling,Ultrasound
More FDA Info for this Device
510(K) Number
K163050
Device Name
Media,Coupling,Ultrasound
Applicant
ADVANCE MEDICAL DESIGNS, INC.
1241 ATLANTA INDUSTRIAL DR.
MARIETTA, GA 30066 US
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Contact
DAVID MACKIE
Other 510(k) Applications for this Contact
Regulation Number
892.1570
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Classification Product Code
MUI
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More FDA Info for this Product Code
Date Received
11/01/2016
Decision Date
10/25/2017
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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