The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Sterilization Boxes.
| Device ID | K160021 |
| 510k Number | K160021 |
| Device Name: | Varian Sterilization Boxes |
| 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 | 2016-01-05 |
| Decision Date | 2016-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025325 | K160021 | 000 |
| 00816389028494 | K160021 | 000 |
| 00816389028333 | K160021 | 000 |
| 00816389028340 | K160021 | 000 |
| 00816389028364 | K160021 | 000 |
| 00816389028371 | K160021 | 000 |
| 00816389020139 | K160021 | 000 |
| 00816389020160 | K160021 | 000 |
| 00816389025295 | K160021 | 000 |
| 00816389025301 | K160021 | 000 |
| 00816389025318 | K160021 | 000 |
| 00816389028449 | K160021 | 000 |