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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K080076
Device Name RX DC X-RAY UNIT
Applicant
Cefla S.C.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact CLAUDE BERTOIN
Correspondent
Cefla S.C.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE BERTOIN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/11/2008
Decision Date 03/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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