The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Arthroscope For Small Joint After Feldkamp, Model 8871.011.
Device ID | K940179 |
510k Number | K940179 |
Device Name: | ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-12 |
Decision Date | 1995-05-23 |