KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR

Accessories, Catheter, G-u

KARL STORZ ENDOSKOP GMBH

The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Karl Storz Catheters, Mandrin, Plugs, Connector.

Pre-market Notification Details

Device IDK951995
510k NumberK951995
Device Name:KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
ClassificationAccessories, Catheter, G-u
Applicant KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City,  CA  90230
ContactJudith K Murphy
CorrespondentJudith K Murphy
KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City,  CA  90230
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-28
Decision Date1995-05-24

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