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FDA 510(k) Application Details - K133206
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K133206
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
ZUMA DENTAL, LLC
27001 LA PAZ ROAD, STE 312
MISSION VIEJO, CA 92691 US
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Contact
ALBERT REGO
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Regulation Number
872.1800
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Classification Product Code
MUH
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Date Received
10/17/2013
Decision Date
05/13/2014
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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