The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Savi Preparation Device.
| Device ID | K101411 |
| 510k Number | K101411 |
| Device Name: | SAVI PREPARATION DEVICE |
| 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-19 |
| Decision Date | 2010-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450433928 | K101411 | 000 |
| 00884450433904 | K101411 | 000 |