RX DC X-RAY UNIT


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

Correspodent Contact claude bertoin
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 01/11/2008
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

Recalls CDRH Recalls