The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Applicators For Varian Varisource Remote High Dose Rate Afterloader.
| Device ID | K955844 |
| 510k Number | K955844 |
| Device Name: | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Contact | Charles H Will |
| Correspondent | Charles H Will 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 | 1995-12-26 |
| Decision Date | 1996-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389021372 | K955844 | 000 |
| 00816389021365 | K955844 | 000 |
| 00816389021358 | K955844 | 000 |
| 00816389021341 | K955844 | 000 |