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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
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