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FDA 510(k) Application Details - K123419
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K123419
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
AFP IMAGING 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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More FDA Info for this Product Code
Date Received
11/06/2012
Decision Date
12/27/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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