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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