ISCIENCE SURGICAL VISCOINJECTOR


Device Classification Name

pump, infusion, ophthalmic

510(k) Number K050716
Device Name ISCIENCE SURGICAL VISCOINJECTOR
Applicant
ISCIENCE SURGICAL CORPORATION
2 delphinus
irvine, 
CA 
92612

Applicant Contact judy f gordon
Correspondent
ISCIENCE SURGICAL CORPORATION
2 delphinus
irvine, 
CA 
92612

Correspodent Contact judy f gordon
Regulation Number 880.5725
Classification Product Code
MRH  
Date Received 03/21/2005
Decision Date 04/21/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No