ROYALE AE 9036 LSP INJECTOR


Device Classification Name

folders and injectors, intraocular lens (iol)

510(k) Number K073010
Device Name ROYALE AE 9036 LSP INJECTOR
Applicant
ASICO LLC
26 plaza dr.
westmont, 
IL 
60559

Applicant Contact ravi nallakrishnan
Regulation Number 886.4300
Classification Product Code
MSS  
Date Received 10/25/2007
Decision Date 11/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No