The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Endometrial Applicator For Varisource Remote High Dose Rate Afterloader.
| Device ID | K980576 |
| 510k Number | K980576 |
| Device Name: | VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1120 |
| Contact | Linda Nash |
| Correspondent | Linda Nash VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1120 |
| 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 | 1998-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389025134 | K980576 | 000 |
| 00810563022193 | K980576 | 000 |
| 00810563022186 | K980576 | 000 |
| 00810563022179 | K980576 | 000 |
| 00810563022162 | K980576 | 000 |
| 00810563022155 | K980576 | 000 |
| 00810563022148 | K980576 | 000 |
| 00810563022131 | K980576 | 000 |
| 00810563022124 | K980576 | 000 |
| 00810563022117 | K980576 | 000 |
| 00810563022094 | K980576 | 000 |
| 00816389028357 | K980576 | 000 |
| 00816389025035 | K980576 | 000 |
| 00816389025127 | K980576 | 000 |
| 00816389025110 | K980576 | 000 |
| 00816389025103 | K980576 | 000 |
| 00816389025097 | K980576 | 000 |
| 00816389025080 | K980576 | 000 |
| 00816389025073 | K980576 | 000 |
| 00816389025066 | K980576 | 000 |
| 00816389025059 | K980576 | 000 |
| 00816389025042 | K980576 | 000 |
| 00810563022100 | K980576 | 000 |