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).
| Device ID | K971420 |
| 510k Number | K971420 |
| Device Name: | MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-17 |
| Decision Date | 1997-10-22 |
| Summary: | summary |