The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Plastic Needle With Mandrin 2.0 Diameter Length 113mm.
| Device ID | K120341 |
| 510k Number | K120341 |
| Device Name: | PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810563022022 | K120341 | 000 |