KOWA GENESIS-D


Device Classification Name

camera, ophthalmic, ac-powered

510(k) Number K080681
Device Name KOWA GENESIS-D
Applicant
KOWA CO. LTD.
4-14, nihonbashi-honcho
3-chome
chuo-ku, tokyo, 

JP

103-8433

Applicant Contact satohiko takanashi
Correspondent
KOWA CO. LTD.
4-14, nihonbashi-honcho
3-chome
chuo-ku, tokyo, 

JP

103-8433

Correspodent Contact satohiko takanashi
Regulation Number 886.1120
Classification Product Code
HKI  
Date Received 03/10/2008
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No