CHROMOPHARE E-SERIES


Device Classification Name

light, surgical, ceiling mounted

510(k) Number K080857
Device Name CHROMOPHARE E-SERIES
Applicant
BERCHTOLD HOLDING GMBH
ludwigstaler strabe 25
tuttlingen, 

DE

d-78532

Applicant Contact silke goral
Regulation Number 878.4580
Classification Product Code
FSY  
Date Received 03/27/2008
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No