ASICO SOFTIP INJECTOR SYSTEM


Device Classification Name

folders and injectors, intraocular lens (iol)

510(k) Number K103495
Device Name ASICO SOFTIP INJECTOR SYSTEM
Applicant
ASICO LLC
26 plaza dr.
westmont, 
IL 
60559

Applicant Contact ravi nallakrishnan
Regulation Number 886.4300
Classification Product Code
MSS  
Date Received 11/29/2010
Decision Date 06/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No