The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Esophagus Bougie Set.
| Device ID | K130251 |
| 510k Number | K130251 |
| Device Name: | ESOPHAGUS BOUGIE SET |
| 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 | 2013-02-01 |
| Decision Date | 2013-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389024731 | K130251 | 000 |
| 00816389023314 | K130251 | 000 |
| 00816389024144 | K130251 | 000 |
| 00816389024151 | K130251 | 000 |
| 00816389024168 | K130251 | 000 |
| 00816389024175 | K130251 | 000 |
| 00816389024182 | K130251 | 000 |
| 00816389024199 | K130251 | 000 |
| 00816389024205 | K130251 | 000 |
| 00816389024212 | K130251 | 000 |
| 00816389024229 | K130251 | 000 |
| 00816389024311 | K130251 | 000 |
| 00816389024625 | K130251 | 000 |
| 00816389021549 | K130251 | 000 |