MYRAY SKYVIEW


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

Correspodent Contact berthoin claude
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 04/16/2008
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