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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Contact Lens Care, Rigid Gas Permeable
510(k) Number K001428
Device Name OPTIMUM WETTING AND REWETTING DROP
Applicant
Lobob Laboratories, Inc.
2000 M St. NW # 700
Washington,  DC  20036 -3307
Applicant Contact DANIEL J MANELLI
Correspondent
Lobob Laboratories, Inc.
2000 M St. NW # 700
Washington,  DC  20036 -3307
Correspondent Contact DANIEL J MANELLI
Regulation Number886.5918
Classification Product Code
MRC  
Date Received05/05/2000
Decision Date 05/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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