The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Savi Applicator Kit.
| Device ID | K081677 |
| 510k Number | K081677 |
| Device Name: | SAVI APPLICATOR KIT |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 Aliso Viejo, CA 92656 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 Aliso Viejo, CA 92656 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450434274 | K081677 | 000 |
| 10884450433949 | K081677 | 000 |
| 00884450434994 | K081677 | 000 |
| 00884450434413 | K081677 | 000 |
| 00884450434383 | K081677 | 000 |
| 00884450434291 | K081677 | 000 |
| 00884450434338 | K081677 | 000 |
| 10884450434236 | K081677 | 000 |