The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, Odd Lengths And Even Lengths, Universal Titanium Cervix Probe Sets, Odd Lengths And Even Lengths.
| Device ID | K172611 |
| 510k Number | K172611 |
| Device Name: | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, Odd Lengths And Even Lengths, Universal Titanium Cervix Probe Sets, Odd Lengths And Even Lengths |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389027701 | K172611 | 000 |
| 00816389027794 | K172611 | 000 |
| 00816389027787 | K172611 | 000 |
| 00816389027770 | K172611 | 000 |
| 00816389027763 | K172611 | 000 |
| 00816389027756 | K172611 | 000 |
| 00816389027749 | K172611 | 000 |
| 00816389027732 | K172611 | 000 |
| 00816389027725 | K172611 | 000 |
| 00816389027800 | K172611 | 000 |
| 00816389027619 | K172611 | 000 |
| 00816389027695 | K172611 | 000 |
| 00816389027688 | K172611 | 000 |
| 00816389027671 | K172611 | 000 |
| 00816389027664 | K172611 | 000 |
| 00816389027657 | K172611 | 000 |
| 00816389027640 | K172611 | 000 |
| 00816389027633 | K172611 | 000 |
| 00816389027626 | K172611 | 000 |
| 00816389027718 | K172611 | 000 |