The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Confidence Fenestrated Introducer Needle.
| Device ID | K063067 |
| 510k Number | K063067 |
| Device Name: | CONFIDENCE FENESTRATED INTRODUCER NEEDLE |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-06 |
| Decision Date | 2006-11-03 |
| Summary: | summary |