The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Varisource Breast Template System.
| Device ID | K023220 |
| 510k Number | K023220 |
| Device Name: | VARISOURCE BREAST TEMPLATE SYSTEM |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
| Contact | Linda S Nash |
| Correspondent | Linda S Nash VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389021235 | K023220 | 000 |
| 00816389020665 | K023220 | 000 |
| 00816389020658 | K023220 | 000 |
| 00816389020641 | K023220 | 000 |
| 00816389020634 | K023220 | 000 |
| 00816389020627 | K023220 | 000 |
| 00816389020610 | K023220 | 000 |
| 00816389020603 | K023220 | 000 |
| 00816389020597 | K023220 | 000 |
| 00816389020580 | K023220 | 000 |
| 00816389020573 | K023220 | 000 |
| 00816389020566 | K023220 | 000 |
| 00816389020559 | K023220 | 000 |
| 00816389020542 | K023220 | 000 |
| 00816389020535 | K023220 | 000 |
| 00816389020528 | K023220 | 000 |
| 00816389020504 | K023220 | 000 |
| 00816389020498 | K023220 | 000 |
| 00816389020672 | K023220 | 000 |
| 00816389020689 | K023220 | 000 |
| 00816389020696 | K023220 | 000 |
| 00816389021228 | K023220 | 000 |
| 00816389020856 | K023220 | 000 |
| 00816389020849 | K023220 | 000 |
| 00816389020832 | K023220 | 000 |
| 00816389020825 | K023220 | 000 |
| 00816389020818 | K023220 | 000 |
| 00816389020801 | K023220 | 000 |
| 00816389020795 | K023220 | 000 |
| 00816389020788 | K023220 | 000 |
| 00816389020771 | K023220 | 000 |
| 00816389020764 | K023220 | 000 |
| 00816389020757 | K023220 | 000 |
| 00816389020740 | K023220 | 000 |
| 00816389020733 | K023220 | 000 |
| 00816389020726 | K023220 | 000 |
| 00816389020719 | K023220 | 000 |
| 00816389020702 | K023220 | 000 |
| 00816389020481 | K023220 | 000 |