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FDA 510(k) Application Details - K171012
Device Classification Name
X-Ray, Tomography, Computed, Dental
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510(K) Number
K171012
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
J.Morita USA, Inc.
9 Mason
Irvine, CA 92618 US
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Contact
Keisuke Mori
Other 510(k) Applications for this Contact
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
04/04/2017
Decision Date
12/19/2017
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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