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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 K071203
Device Name SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
Applicant
Optikem International, Inc.
2214 Sanford Dr. Unit B7
Grand Junction,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
Optikem International, Inc.
2214 Sanford Dr. Unit B7
Grand Junction,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5928
Classification Product Code
LPN  
Date Received05/01/2007
Decision Date 06/13/2007
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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