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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K860794
Device Name WRAPPERS, SUNGLASSES
Applicant
Mhci Corp.
695 W. Ter. Dr.
San Dimas,  CA  91773
Applicant Contact MICHAEL MURPHY
Correspondent
Mhci Corp.
695 W. Ter. Dr.
San Dimas,  CA  91773
Correspondent Contact MICHAEL MURPHY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/04/1986
Decision Date 04/21/1986
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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