EYE-CEPT STERILE SALINE SOLUTION


Device Classification Name

accessories, soft lens products

510(k) Number K110221
Device Name EYE-CEPT STERILE SALINE SOLUTION
Applicant
OPTICS LABORATORY, INC
9480 telstar ave
suite 3
el monte, 
CA 
91731 -2988

Applicant Contact patricia chiu
Correspondent
OPTICS LABORATORY, INC
9480 telstar ave
suite 3
el monte, 
CA 
91731 -2988

Correspodent Contact patricia chiu
Regulation Number 886.5928
Classification Product Code
LPN  
Date Received 01/25/2011
Decision Date 11/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No