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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861333
Device Name ULTRA-VIOLET GOGGLETS
Applicant
Health Saver Products
Post Office Box 39
183 S. Service Rd.
Grimsby, On Canada,  CA L3M 4G1
Applicant Contact ED MALONEY
Correspondent
Health Saver Products
Post Office Box 39
183 S. Service Rd.
Grimsby, On Canada,  CA L3M 4G1
Correspondent Contact ED MALONEY
Date Received04/09/1986
Decision Date 04/28/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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