The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Surface Applicator Set With Leipzig-style Cone.
| Device ID | K123815 |
| 510k Number | K123815 |
| Device Name: | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94303 |
| Contact | Peter J Coronado |
| Correspondent | Peter J Coronado VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94303 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025202 | K123815 | 000 |
| 00816389025196 | K123815 | 000 |
| 00816389022782 | K123815 | 000 |
| 00816389022775 | K123815 | 000 |
| 00816389022768 | K123815 | 000 |
| 00816389022706 | K123815 | 000 |