ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452

Endoscope, Neurological

RICHARD WOLF MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Endoscope Set For Magnetic Resonance (mr), Models 8767.412, 8767.121 & 8767.452.

Pre-market Notification Details

Device IDK022198
510k NumberK022198
Device Name:ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
ClassificationEndoscope, Neurological
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills,  IL  60061
ContactRobert L Casarsa
CorrespondentRobert L Casarsa
RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills,  IL  60061
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-05
Decision Date2003-03-21
Summary:summary

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