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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 K875063
Device Name SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.
Applicant
Epson EL Paso, Inc.
2000 Mbank Plz.
P.O. Drawer 2800
El Paso,  TX  79901
Applicant Contact SCANLON, JR
Correspondent
Epson EL Paso, Inc.
2000 Mbank Plz.
P.O. Drawer 2800
El Paso,  TX  79901
Correspondent Contact SCANLON, JR
Regulation Number886.5844
Classification Product Code
HQG  
Date Received12/09/1987
Decision Date 02/22/1988
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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