The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Microblade Shaver And Accessories.
| Device ID | K063231 |
| 510k Number | K063231 |
| Device Name: | MICROBLADE SHAVER AND ACCESSORIES |
| 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 | 2006-10-25 |
| Decision Date | 2007-04-16 |
| Summary: | summary |