The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Heyman Packing Applicator Set.
| Device ID | K160045 |
| 510k Number | K160045 |
| Device Name: | Heyman Packing Applicator Set |
| 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 | 2016-01-08 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389023604 | K160045 | 000 |
| 00816389023475 | K160045 | 000 |
| 00816389023413 | K160045 | 000 |