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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K881739
Device Name LENZ CLENZER
Applicant
Lens Care, Inc.
2755 E. Oakland Park Blvd.
Ft. Lauderdale,  FL  33306
Applicant Contact JAMES A GRAHAM
Correspondent
Lens Care, Inc.
2755 E. Oakland Park Blvd.
Ft. Lauderdale,  FL  33306
Correspondent Contact JAMES A GRAHAM
Regulation Number886.5928
Classification Product Code
LYL  
Date Received04/25/1988
Decision Date 10/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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