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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K973229
Device Name D.O.R.C. HEXON ILLUMINATION 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 Number876.1500
Classification Product Code
MPA  
Date Received08/27/1997
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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