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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K980636
Device Name FIBER OPTIC ENDOILLUMINATION PROBE
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
FFS  
Date Received02/19/1998
Decision Date 05/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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