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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K950166
Device Name OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY E SANDS
Regulation Number876.4300
Classification Product Code
KNS  
Date Received01/17/1995
Decision Date 02/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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