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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 K884360
Device Name SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
Applicant
SEIKO CORP.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact ROBERT L CURLEY
Correspondent
SEIKO CORP.
575 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact ROBERT L CURLEY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received10/17/1988
Decision Date 11/15/1988
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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