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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K963434
Device Name VISCOUS FLUID SYSTEM
Applicant
Escalon Trek Medical
822 Swan Dr.
Mukwonago,  WI  53149
Applicant Contact RONALD L HUENEKE
Correspondent
Escalon Trek Medical
822 Swan Dr.
Mukwonago,  WI  53149
Correspondent Contact RONALD L HUENEKE
Regulation Number880.5725
Classification Product Code
MRH  
Date Received08/30/1996
Decision Date 11/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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