The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Biopsy Site Tissue Marker Device.
| Device ID | K023450 |
| 510k Number | K023450 |
| Device Name: | BIOPSY SITE TISSUE MARKER DEVICE |
| Classification | Marker, Radiographic, Implantable |
| Applicant | PROMEX, INC. 3049 HUDSON ST. Franklin, IN 46131 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 3049 HUDSON ST. Franklin, IN 46131 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503581 | K023450 | 000 |
| 05420045503284 | K023450 | 000 |
| 05420045503291 | K023450 | 000 |
| 05420045503307 | K023450 | 000 |
| 05420045503314 | K023450 | 000 |
| 05420045503321 | K023450 | 000 |
| 05420045503338 | K023450 | 000 |
| 05420045503345 | K023450 | 000 |
| 05420045503352 | K023450 | 000 |
| 05420045503369 | K023450 | 000 |
| 05420045503376 | K023450 | 000 |
| 05420045503383 | K023450 | 000 |
| 05420045503550 | K023450 | 000 |
| 05420045503567 | K023450 | 000 |
| 05420045503574 | K023450 | 000 |
| 05420045503277 | K023450 | 000 |