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FDA 510(k) Application Details - K110260
Device Classification Name
X-Ray, Tomography, Computed, Dental
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510(K) Number
K110260
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
QR S.R.L.
VIA SILVESTRINI 20
VERONA, VR 37135 IT
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Contact
LORENZO BORTOLOTTI
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Regulation Number
892.1750
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Classification Product Code
OAS
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Date Received
01/28/2011
Decision Date
04/06/2011
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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