The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Intraluminal Applicator Set.
| Device ID | K151022 |
| 510k Number | K151022 |
| Device Name: | Intraluminal Applicator 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 | 2015-04-16 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389026155 | K151022 | 000 |
| 00816389021532 | K151022 | 000 |
| 00816389021563 | K151022 | 000 |
| 00816389021587 | K151022 | 000 |
| 00816389021600 | K151022 | 000 |
| 00816389022461 | K151022 | 000 |
| 00816389022485 | K151022 | 000 |
| 00816389023789 | K151022 | 000 |
| 00816389024588 | K151022 | 000 |
| 00816389021419 | K151022 | 000 |