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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K942407
Device Name AMCON SLIP IN MYDRIATIC SUNGLASSES
Applicant
Amcon Laboratories, Inc.
19916 SE 19th St.
Issaquah,  WA  98027
Applicant Contact ANDREA R FRIEDMAN
Correspondent
Amcon Laboratories, Inc.
19916 SE 19th St.
Issaquah,  WA  98027
Correspondent Contact ANDREA R FRIEDMAN
Regulation Number886.4750
Classification Product Code
HOY  
Date Received05/20/1994
Decision Date 06/06/1994
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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