The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Ultra Low Profile Rongeur.
| Device ID | K062711 |
| 510k Number | K062711 |
| Device Name: | ULTRA LOW PROFILE RONGEUR |
| Classification | Rongeur, Manual |
| Applicant | BAXANO, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell BAXANO, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2007-03-07 |
| Summary: | summary |