MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)

Hysteroscope (and Accessories)

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 Microendoscope(8755.401,411,461,451)/external Sheath(8755.221,222)/veress Cannula(8755.211,212).

Pre-market Notification Details

Device IDK971420
510k NumberK971420
Device Name:MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)
ClassificationHysteroscope (and Accessories)
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 CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-17
Decision Date1997-10-22
Summary:summary

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