RALCO


Device Classification Name

collimator, manual, radiographic

510(k) Number K110856
Device Name RALCO
Applicant
RALCO S.R.L.
8870 ravello ct
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
RALCO S.R.L.
8870 ravello ct
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 892.1610
Classification Product Code
IZX  
Date Received 03/28/2011
Decision Date 08/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No