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FDA 510(k) Application Details - K232166
Device Classification Name
X-Ray, Tomography, Computed, Dental
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510(K) Number
K232166
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
PreXion Corporation
1-14-1, Kandasuda-cho
Chiyoda-ku 101-0041 JP
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Contact
Kenji Tanaka
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Regulation Number
892.1750
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Classification Product Code
OAS
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More FDA Info for this Product Code
Date Received
07/21/2023
Decision Date
09/08/2023
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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