The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Bravos Afterloader System, Transfer Guide Tubes, Length Assessment Device.
| Device ID | K191580 |
| 510k Number | K191580 |
| Device Name: | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389028197 | K191580 | 000 |
| 00816389028852 | K191580 | 000 |