ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER


Device Classification Name

endoilluminator

510(k) Number K080067
Device Name ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
Applicant
ISCIENCE INTERVENTIONAL
4055 campbell avenue
menlo park, 
CA 
94025

Applicant Contact grace bartoo
Correspondent
ISCIENCE INTERVENTIONAL
4055 campbell avenue
menlo park, 
CA 
94025

Correspodent Contact grace bartoo
Regulation Number 876.1500
Classification Product Code
MPA  
Subsequent Product Code
HMX  
Date Received 01/10/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No