The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Centering Intraluminal Applicator.
| Device ID | K082653 |
| 510k Number | K082653 |
| Device Name: | CENTERING INTRALUMINAL APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 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 | 2008-09-12 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389024779 | K082653 | 000 |
| 00816389022003 | K082653 | 000 |
| 00816389022171 | K082653 | 000 |
| 00816389024458 | K082653 | 000 |
| 00816389024465 | K082653 | 000 |
| 00816389024472 | K082653 | 000 |
| 00816389024540 | K082653 | 000 |
| 00816389024557 | K082653 | 000 |
| 00816389024564 | K082653 | 000 |
| 00816389024748 | K082653 | 000 |
| 00816389021594 | K082653 | 000 |