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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 K950940
Device Name OPTI PADS
Applicant
Karlen Mfg., Inc.
5401 S Graham Rd.
St. Charles,  MI  48655
Applicant Contact LENDELL J WILLIAMS
Correspondent
Karlen Mfg., Inc.
5401 S Graham Rd.
St. Charles,  MI  48655
Correspondent Contact LENDELL J WILLIAMS
Regulation Number886.5928
Classification Product Code
LYL  
Date Received02/27/1995
Decision Date 06/26/1995
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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