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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K895813
Device Name GLAUCOMA MECHANICAL TREPHINE
Applicant
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
Trek Medical Products, Inc.
820 Swan Dr.
P.O. Box B
Muckwonago,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number886.4150
Classification Product Code
HQE  
Date Received10/02/1989
Decision Date 04/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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