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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 K030987
Device Name CONTACT LENS STORAGE CASE
Applicant
Pelican Products
611 Eisenhauer St.
Grnad Junction,  CO  81505
Applicant Contact CAROL NOBEL
Correspondent
Pelican Products
611 Eisenhauer St.
Grnad Junction,  CO  81505
Correspondent Contact CAROL NOBEL
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/28/2003
Decision Date 06/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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