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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 K872164
Device Name RESTORE
Applicant
Anderson Research, Inc.
7199 Sunbury Rd.
Westerville,  OH  43081
Applicant Contact RONALD ANDERSON
Correspondent
Anderson Research, Inc.
7199 Sunbury Rd.
Westerville,  OH  43081
Correspondent Contact RONALD ANDERSON
Regulation Number886.5928
Classification Product Code
LPN  
Date Received06/05/1987
Decision Date 09/17/1987
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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