The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Interstitial Titanium Needles.
| Device ID | K093291 |
| 510k Number | K093291 |
| Device Name: | VARIAN INTERSTITIAL TITANIUM NEEDLES |
| 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 | 2009-10-21 |
| Decision Date | 2009-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025363 | K093291 | 000 |
| 00816389029392 | K093291 | 000 |
| 00816389029385 | K093291 | 000 |
| 00816389029378 | K093291 | 000 |
| 00816389029361 | K093291 | 000 |
| 00816389029354 | K093291 | 000 |
| 00816389029347 | K093291 | 000 |
| 00816389029330 | K093291 | 000 |
| 00816389029323 | K093291 | 000 |
| 00816389029316 | K093291 | 000 |
| 00816389029309 | K093291 | 000 |
| 00816389029408 | K093291 | 000 |
| 00816389024953 | K093291 | 000 |
| 00816389024960 | K093291 | 000 |
| 00816389025356 | K093291 | 000 |
| 00816389025349 | K093291 | 000 |
| 00816389025332 | K093291 | 000 |
| 00816389025264 | K093291 | 000 |
| 00816389025257 | K093291 | 000 |
| 00816389025240 | K093291 | 000 |
| 00816389025233 | K093291 | 000 |
| 00816389025219 | K093291 | 000 |
| 00816389024984 | K093291 | 000 |
| 00816389024977 | K093291 | 000 |
| 00816389029293 | K093291 | 000 |