KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES

Arthroscope

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 Karl Storz Semi-rigid Micro-endoscopes And Accessories For Endoscopic Arthroscopy Procedures.

Pre-market Notification Details

Device IDK945787
510k NumberK945787
Device Name:KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES
ClassificationArthroscope
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-25
Decision Date1995-06-13

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