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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K915082
Device Name OPTI-LENS(TM) CONTACT LENS CASE
Applicant
Ryder Intl. Corp.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Applicant Contact PATRICIA BRADSTREET
Correspondent
Ryder Intl. Corp.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Correspondent Contact PATRICIA BRADSTREET
Regulation Number886.5928
Classification Product Code
LRX  
Date Received11/12/1991
Decision Date 01/13/1992
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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