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FDA 510(k) Application Details - K170930
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device
510(K) Number
K170930
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
DRTECH Corporation
Suit No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil
Jungwon-gu
Seongnam-si 13230 KR
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Contact
Choul-Woo Shin
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MUE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/2017
Decision Date
04/27/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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