FUNS-10, FUNS-11

Ureteroscope And Accessories, Flexible/rigid

REICHERT-JUNG, INC.

The following data is part of a premarket notification filed by Reichert-jung, Inc. with the FDA for Funs-10, Funs-11.

Pre-market Notification Details

Device IDK862551
510k NumberK862551
Device Name:FUNS-10, FUNS-11
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge,  MA  01550
ContactRichard F Taylor
CorrespondentRichard F Taylor
REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge,  MA  01550
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-03
Decision Date1986-09-12

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