The following data is part of a premarket notification filed by Havel's, Inc. with the FDA for Echostim Facet Tip.
| Device ID | K063380 |
| 510k Number | K063380 |
| Device Name: | ECHOSTIM FACET TIP |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | HAVEL'S, INC. 3726 LONSDALE ST. Cincinnati, OH 45227 |
| Contact | Patrick Carrothers |
| Correspondent | Patrick Carrothers HAVEL'S, INC. 3726 LONSDALE ST. Cincinnati, OH 45227 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2007-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14526737170753 | K063380 | 000 |
| 10888277862579 | K063380 | 000 |
| 10193489229349 | K063380 | 000 |
| 40888277832436 | K063380 | 000 |
| 40193489253024 | K063380 | 000 |
| 14526737171231 | K063380 | 000 |
| 14526737171224 | K063380 | 000 |
| 14526737171217 | K063380 | 000 |
| 14526737171200 | K063380 | 000 |
| 14526737171194 | K063380 | 000 |
| 04526737171180 | K063380 | 000 |
| 14526737171170 | K063380 | 000 |
| 04526737171166 | K063380 | 000 |
| 14526737171156 | K063380 | 000 |
| 04526737171142 | K063380 | 000 |
| 14526737171118 | K063380 | 000 |
| 14526737171125 | K063380 | 000 |
| 14526737170746 | K063380 | 000 |
| 14526737170739 | K063380 | 000 |
| 14526737170722 | K063380 | 000 |
| 14526737170715 | K063380 | 000 |
| 14526737170708 | K063380 | 000 |
| 14526737170692 | K063380 | 000 |
| 14526737170685 | K063380 | 000 |
| 14526737170678 | K063380 | 000 |
| 14526737170661 | K063380 | 000 |
| 14526737170654 | K063380 | 000 |
| 14526737170647 | K063380 | 000 |
| 14526737170630 | K063380 | 000 |
| 14526737170623 | K063380 | 000 |
| 14526737170616 | K063380 | 000 |
| 14526737171132 | K063380 | 000 |