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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Replacement, Phacofragmentation Unit
510(k) Number K983448
Device Name ML UNIVERSAL TUBING
Applicant
Med-Logics, Inc.
30251 Golden Lantern
Suite E-207
Laguna Niguel,  CA  92677
Applicant Contact BETTY ROSS
Correspondent
Med-Logics, Inc.
30251 Golden Lantern
Suite E-207
Laguna Niguel,  CA  92677
Correspondent Contact BETTY ROSS
Regulation Number886.4150
Classification Product Code
MSR  
Date Received09/30/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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