GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72


Device Classification Name

biomicroscope, slit-lamp, ac-powered

510(k) Number K080776
Device Name GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
Applicant
USOPHTHALMIC, LLC
7255 nw 88th street
unit 9
miami, 
FL 
33166

Applicant Contact al weisenborn
Correspondent
USOPHTHALMIC, LLC
7255 nw 88th street
unit 9
miami, 
FL 
33166

Correspodent Contact al weisenborn
Regulation Number 886.1850
Classification Product Code
HJO  
Date Received 03/19/2008
Decision Date 09/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No