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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 K972522
Device Name ML-DISPOSABLE PAK
Applicant
Med-Logics, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
Med-Logics, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number886.4150
Classification Product Code
MSR  
Date Received07/07/1997
Decision Date 09/30/1997
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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