The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for B-twin Bone Expander System (b-twin Be System).
| Device ID | K032358 |
| 510k Number | K032358 |
| Device Name: | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) |
| Classification | Arthroscope |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonanthan S Kahn |
| Correspondent | Jonanthan S Kahn DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-30 |
| Decision Date | 2003-12-17 |
| Summary: | summary |