The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Modification To: Microblade Shaver And Accessories.
| Device ID | K100958 |
| 510k Number | K100958 |
| Device Name: | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES |
| Classification | Rongeur, Manual |
| Applicant | BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Contact | Edward J Sinclair |
| Correspondent | Edward J Sinclair BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-07 |
| Decision Date | 2010-07-23 |
| Summary: | summary |