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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 K861684
Device Name SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
Applicant
SEIKO OPTICAL PRODUCTS OF AMERICA, INC.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact ROBERT CURLEY
Correspondent
SEIKO OPTICAL PRODUCTS OF AMERICA, INC.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact ROBERT CURLEY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received05/02/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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