LORAD 1-650 (INTERNATIONAL 650)


Device Classification Name

system, x-ray, mammographic

510(k) Number K992280
Device Name LORAD 1-650 (INTERNATIONAL 650)
Applicant
LORAD CORP.
36 apple ridge rd.
danbury, 
CT 
06810

Applicant Contact kelvin burroughs
Correspondent
LORAD CORP.
36 apple ridge rd.
danbury, 
CT 
06810

Correspodent Contact kelvin burroughs
Regulation Number 892.1710
Classification Product Code
IZH  
Date Received 07/07/1999
Decision Date 09/03/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized