The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets.
| Device ID | K152018 |
| 510k Number | K152018 |
| Device Name: | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets |
| 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 | 2015-07-21 |
| Decision Date | 2015-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025486 | K152018 | 000 |
| 00816389028678 | K152018 | 000 |
| 00816389028661 | K152018 | 000 |
| 00816389028654 | K152018 | 000 |
| 00816389028647 | K152018 | 000 |
| 00816389028630 | K152018 | 000 |
| 00816389028616 | K152018 | 000 |
| 00816389028609 | K152018 | 000 |
| 00816389028593 | K152018 | 000 |
| 00816389028586 | K152018 | 000 |
| 00816389028579 | K152018 | 000 |
| 00816389028562 | K152018 | 000 |
| 00816389028555 | K152018 | 000 |
| 00816389028548 | K152018 | 000 |
| 00816389028531 | K152018 | 000 |
| 00816389028524 | K152018 | 000 |
| 00816389028517 | K152018 | 000 |
| 00816389028500 | K152018 | 000 |
| 00816389028685 | K152018 | 000 |
| 00816389028692 | K152018 | 000 |
| 00816389025400 | K152018 | 000 |
| 00816389025394 | K152018 | 000 |
| 00816389022881 | K152018 | 000 |
| 00816389028821 | K152018 | 000 |
| 00816389028814 | K152018 | 000 |
| 00816389028623 | K152018 | 000 |
| 00816389028807 | K152018 | 000 |
| 00816389028791 | K152018 | 000 |
| 00816389028784 | K152018 | 000 |
| 00816389028777 | K152018 | 000 |
| 00816389028760 | K152018 | 000 |
| 00816389028753 | K152018 | 000 |
| 00816389028746 | K152018 | 000 |
| 00816389028739 | K152018 | 000 |
| 00816389028722 | K152018 | 000 |
| 00816389028715 | K152018 | 000 |
| 00816389028708 | K152018 | 000 |
| 00816389028326 | K152018 | 000 |