The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Interstitial Needles.
| Device ID | K073133 |
| 510k Number | K073133 |
| Device Name: | INTERSTITIAL 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 | 2007-11-07 |
| Decision Date | 2007-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025028 | K073133 | 000 |
| 00816389024793 | K073133 | 000 |
| 00816389024809 | K073133 | 000 |
| 00816389024816 | K073133 | 000 |
| 00816389024823 | K073133 | 000 |
| 00816389024830 | K073133 | 000 |
| 00816389024847 | K073133 | 000 |
| 00816389024854 | K073133 | 000 |
| 00816389024991 | K073133 | 000 |
| 00816389025004 | K073133 | 000 |
| 00816389025011 | K073133 | 000 |
| 00816389024786 | K073133 | 000 |