The following data is part of a premarket notification filed by Cianna Medical with the FDA for Cianna S1, Single Lumen Balloon Applicator Kit.
| Device ID | K103215 |
| 510k Number | K103215 |
| Device Name: | CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | CIANNA MEDICAL 6 JOURNEY, SUITE 125 Aliso Viejo, CA 92656 |
| Contact | Gary Mocnik |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2010-11-15 |
| Summary: | summary |