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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 K921615
Device Name LENSONIC(TM) CONTACT LENS CARE ACCESSORY
Applicant
Personal Professional Products, Inc.
C/O Acorn Group, Inc.
47 Quail Ct., Suite 301
Walnut Creek,  CA  94596
Applicant Contact JAMES P STOUT
Correspondent
Personal Professional Products, Inc.
C/O Acorn Group, Inc.
47 Quail Ct., Suite 301
Walnut Creek,  CA  94596
Correspondent Contact JAMES P STOUT
Regulation Number886.5928
Classification Product Code
LYL  
Date Received04/06/1992
Decision Date 11/05/1992
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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