The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Esophagus Bougie Set.
| Device ID | K161576 |
| 510k Number | K161576 |
| Device Name: | Esophagus Bougie Set |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 911 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 | 2016-06-07 |
| Decision Date | 2016-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389027411 | K161576 | 000 |