The following data is part of a premarket notification filed by Envisioneering, Llc. with the FDA for Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide.
| Device ID | K073399 |
| 510k Number | K073399 |
| Device Name: | TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE |
| Classification | Biopsy Needle |
| Applicant | ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis, MO 63114 |
| Contact | David Kennedy |
| Correspondent | David Kennedy ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR St. Louis, MO 63114 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2007-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852656007465 | K073399 | 000 |
| 00852656007458 | K073399 | 000 |
| 00852656007441 | K073399 | 000 |
| 00852656007434 | K073399 | 000 |