The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varisource Wright Vaginal Cuff Applicator For Varian Varisource Remote High Dose Rate Afterioader.
| Device ID | K980601 |
| 510k Number | K980601 |
| Device Name: | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Contact | Linda Nash |
| Correspondent | Linda Nash VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-10-21 |
| Summary: | summary |