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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K871714
Device Name KESTREL CONTACT LENS CASE
Applicant
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Applicant Contact ANTHONY J MORAVEC
Correspondent
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Correspondent Contact ANTHONY J MORAVEC
Regulation Number886.5928
Classification Product Code
LPN  
Date Received05/04/1987
Decision Date 05/26/1987
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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