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FDA 510(k) Application Details - K213278
Device Classification Name
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device
510(K) Number
K213278
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
Planmed Oy
Sorvaajankatu 7
Helsinki 00880 FI
Other 510(k) Applications for this Company
Contact
Niina Vuorikallas
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
OAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2021
Decision Date
04/28/2022
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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