MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION

Endoscopic Irrigation/suction System

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Model 27084 Uromat For Urological Irrigation.

Pre-market Notification Details

Device IDK883173
510k NumberK883173
Device Name:MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
ClassificationEndoscopic Irrigation/suction System
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
ContactRobert Giorgini
CorrespondentRobert Giorgini
KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City,  CA  90232 -3578
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-27
Decision Date1988-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.