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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 K853727
Device Name KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)
Applicant
Ryder Intl. Corp.
100 Curt Francis Rd.
Post Office Box 564
Arab,  AL  35016
Applicant Contact ANTHONY MORAVEC
Correspondent
Ryder Intl. Corp.
100 Curt Francis Rd.
Post Office Box 564
Arab,  AL  35016
Correspondent Contact ANTHONY MORAVEC
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/06/1985
Decision Date 02/07/1986
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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