RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES

Resectoscope

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 Resection Pump, Resectoscope For Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories.

Pre-market Notification Details

Device IDK042523
510k NumberK042523
Device Name:RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
ClassificationResectoscope
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 CodeFJL  
Subsequent Product CodeHIH
Subsequent Product CodeKQT
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-17
Decision Date2005-03-18
Summary:summary

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