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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K081088
Device Name MYRAY SKYVIEW
Applicant
Cefla S.C.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact BERTHOIN CLAUDE
Correspondent
Cefla S.C.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact BERTHOIN CLAUDE
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/16/2008
Decision Date 11/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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