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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K862551
Device Name FUNS-10, FUNS-11
Applicant
REICHERT-JUNG, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact RICHARD F TAYLOR
Correspondent
REICHERT-JUNG, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact RICHARD F TAYLOR
Regulation Number876.1500
Classification Product Code
FGB  
Date Received07/03/1986
Decision Date 09/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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