The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Kelowna Gyn And Crook Prostate Templates.
| Device ID | K162533 |
| 510k Number | K162533 |
| Device Name: | Kelowna GYN And Crook Prostate Templates |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389020153 | K162533 | 000 |
| 00816389020054 | K162533 | 000 |
| 00816389020061 | K162533 | 000 |
| 00816389020078 | K162533 | 000 |
| 00816389020085 | K162533 | 000 |
| 00816389020092 | K162533 | 000 |
| 00816389020108 | K162533 | 000 |
| 00816389020122 | K162533 | 000 |
| 00816389020146 | K162533 | 000 |
| 00816389020047 | K162533 | 000 |