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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 K990044
Device Name LOBOB UNIVERSAL CONTACT LENS CLEANER
Applicant
Lobob Laboratories, Inc.
2000 M St., NW #700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Lobob Laboratories, Inc.
2000 M St., NW #700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/06/1999
Decision Date 02/11/1999
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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