The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Shielded Applicator Set, Cervical Stop.
| Device ID | K151657 |
| 510k Number | K151657 |
| Device Name: | Shielded Applicator Set, Cervical Stop |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado 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 | 2015-06-19 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389023178 | K151657 | 000 |
| 00816389022157 | K151657 | 000 |
| 00816389022577 | K151657 | 000 |
| 00816389022584 | K151657 | 000 |
| 00816389022591 | K151657 | 000 |
| 00816389022614 | K151657 | 000 |
| 00816389022638 | K151657 | 000 |
| 00816389022645 | K151657 | 000 |
| 00816389022652 | K151657 | 000 |
| 00816389022669 | K151657 | 000 |
| 00816389022676 | K151657 | 000 |
| 00816389022683 | K151657 | 000 |
| 00816389022690 | K151657 | 000 |
| 00816389022751 | K151657 | 000 |
| 00816389022843 | K151657 | 000 |
| 00816389022911 | K151657 | 000 |
| 00816389022928 | K151657 | 000 |
| 00816389021624 | K151657 | 000 |