PARKONE


Device Classification Name

device,analysis,anterior segment

510(k) Number K073508
Device Name PARKONE
Applicant
OCULUS OPTIKGERATE GMBH
munchholzhauser str. 29
wetzlar, 

DE

d-35582

Applicant Contact joerg iwanczuk
Correspondent
OCULUS OPTIKGERATE GMBH
munchholzhauser str. 29
wetzlar, 

DE

d-35582

Correspodent Contact joerg iwanczuk
Regulation Number 886.1850
Classification Product Code
MXK  
Subsequent Product Codes
HKO   HLQ  
Date Received 12/13/2007
Decision Date 09/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No