ENDO IRRIGATOR 2211, INCLUDING TUBING

Laparoscope, General & Plastic Surgery

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 Endo Irrigator 2211, Including Tubing.

Pre-market Notification Details

Device IDK951715
510k NumberK951715
Device Name:ENDO IRRIGATOR 2211, INCLUDING TUBING
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-13
Decision Date1995-05-12

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