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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K942513
Device Name SEIKO EYEGLASS FRAME
Applicant
Seiko Optical Products of America, Inc.
575 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact DANIEL MATHIS
Correspondent
Seiko Optical Products of America, Inc.
575 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact DANIEL MATHIS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received05/26/1994
Decision Date 07/15/1994
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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