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FDA 510(k) Application Details - K180561
Device Classification Name
Unit, X-Ray, Extraoral With Timer
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510(K) Number
K180561
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
Denterprise International, Inc.
100 E. Granada Blvd., Suite 219
Ormond Beach, FL 32176 US
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Contact
Claude Berthoin
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Regulation Number
872.1800
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Classification Product Code
EHD
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More FDA Info for this Product Code
Date Received
03/05/2018
Decision Date
04/04/2018
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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