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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 K130753
Device Name STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
Applicant
Watchdog Group, LC
7800 Forsyth Blvd.
8th Floor
Clayton,  MO  63105
Applicant Contact JOHN O'HARA
Correspondent
Watchdog Group, LC
7800 Forsyth Blvd.
8th Floor
Clayton,  MO  63105
Correspondent Contact JOHN O'HARA
Regulation Number886.5928
Classification Product Code
LRX  
Date Received03/19/2013
Decision Date 06/13/2013
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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