LEICA FL800


Device Classification Name

system, x-ray, angiographic

510(k) Number K080612
Device Name LEICA FL800
Applicant
LEICA MICROSYSTEMS (SCHWEIZ) AG
1717 west collins
orange, 
CA 
92867

Applicant Contact colleen boswell
Correspondent
LEICA MICROSYSTEMS (SCHWEIZ) AG
1717 west collins
orange, 
CA 
92867

Correspodent Contact colleen boswell
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 03/04/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No