BELLA


Device Classification Name

system, x-ray, mammographic

510(k) Number K073262
Device Name BELLA
Applicant
BEEKLEY CORP.
150 dolphin rd.
bristol, 
CT 
06011

Applicant Contact martine m boutte
Correspondent
BEEKLEY CORP.
150 dolphin rd.
bristol, 
CT 
06011

Correspodent Contact martine m boutte
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 11/20/2007
Decision Date 03/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls