HOYA IS INJECTOR SYSTEM


Device Classification Name

folders and injectors, intraocular lens (iol)

510(k) Number K081346
Device Name HOYA IS INJECTOR SYSTEM
Applicant
HOYA SURGICAL OPTICS, INC.
14768 pipeline ave.
chino hills, 
CA 
91709

Applicant Contact steven l ziemba
Correspondent
HOYA SURGICAL OPTICS, INC.
14768 pipeline ave.
chino hills, 
CA 
91709

Correspodent Contact steven l ziemba
Regulation Number 886.4300
Classification Product Code
MSS  
Date Received 05/14/2008
Decision Date 03/23/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No