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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 K042578
Device Name I-PROMOTIONS CONTACT LENS CASE
Applicant
I-Promotions, Inc.
9522 Gravois Rd.
St. Louis,  MO  63123
Applicant Contact CHARLOTTE SLANKARD
Correspondent
I-Promotions, Inc.
9522 Gravois Rd.
St. Louis,  MO  63123
Correspondent Contact CHARLOTTE SLANKARD
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/22/2004
Decision Date 01/25/2005
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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