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FDA 510(k) Application Details - K203346
Device Classification Name
More FDA Info for this Device
510(K) Number
K203346
Device Name
OEC 3D
Applicant
GE OEC Medical Systems, Inc.
384 N Wright Brothers Drive
Salt Lake City, UT 84116 US
Other 510(k) Applications for this Company
Contact
Kenny M. Bello
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OXO
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More FDA Info for this Product Code
Date Received
11/13/2020
Decision Date
03/05/2021
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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