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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 K983797
Device Name D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
Applicant
Dutch Ophthalmic USA, Inc.
One Little River Rd.
Kingston,  NH  03848
Applicant Contact MARK W FURLONG
Correspondent
Dutch Ophthalmic USA, Inc.
One Little River Rd.
Kingston,  NH  03848
Correspondent Contact MARK W FURLONG
Regulation Number886.4150
Classification Product Code
HQE  
Date Received10/28/1998
Decision Date 03/03/1999
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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