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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 K951182
Device Name RYDER CONTACT LENS CASE MODEL 10670
Applicant
Bradstreet Clinical Research Assoc., Inc.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Applicant Contact PATRICIA W BRADSTREET
Correspondent
Bradstreet Clinical Research Assoc., Inc.
1588 Rte. 130 N.,
Suite C-2
Brunswick,  NJ  08902
Correspondent Contact PATRICIA W BRADSTREET
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/16/1995
Decision Date 05/16/1995
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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