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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 K901748
Device Name KESTREL LENS CASE (208-12NT POLYSTYRENE)
Applicant
Kestrel
3240 N. Indianapolis Rd.
P.O. Box 448
Columbus,  IN  47202
Applicant Contact ANTHONY J MORAVEC
Correspondent
Kestrel
3240 N. Indianapolis Rd.
P.O. Box 448
Columbus,  IN  47202
Correspondent Contact ANTHONY J MORAVEC
Regulation Number886.5928
Classification Product Code
LRX  
Date Received04/17/1990
Decision Date 05/31/1990
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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