The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Flexible Nasopharyngo-laryngoscopes, Flexible Bronchoscope.
Device ID | K992526 |
510k Number | K992526 |
Device Name: | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Contact | Robert L Casarsa |
Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-28 |
Decision Date | 1999-09-24 |
Summary: | summary |