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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Soft-Lens, Thermal, Ac-Powered
510(k) Number K822828
Device Name SOFT LENS THERMAL DISINFECTING UNIT, A-C
Applicant
Safeway Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Safeway Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.5928
Classification Product Code
HRD  
Date Received09/21/1982
Decision Date 10/29/1982
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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