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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K161622
Device Name LensGiene Sterile Saline Solution
Applicant
Optics Laboratory, Inc.
9480 Telstar Ave. Suite 3
El Monte,  CA  91731
Applicant Contact Patricia Chiu
Correspondent
Rockin' Regulatory, Inc.
21831 Tumbleweed Cir.
Lake Forest,  CA  92630
Correspondent Contact Paul Kramsky
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received06/13/2016
Decision Date 08/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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