FDA 510(k) Application Details - K141130

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K141130
Device Name System,X-Ray,Extraoral Source,Digital
Applicant PANORAMIC CORP.
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact DANIEL KAMM, P.E.
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 05/01/2014
Decision Date 07/30/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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