The following data is part of a premarket notification filed by Cianna Medical with the FDA for Cianna Medical Tissue Marker And Delivery System.
| Device ID | K120804 |
| 510k Number | K120804 |
| Device Name: | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM |
| Classification | Temporary Tissue Marker |
| Applicant | CIANNA MEDICAL 6 JOURNEY, SUITE 125 Aliso Viejo, CA 92656 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik CIANNA MEDICAL 6 JOURNEY, SUITE 125 Aliso Viejo, CA 92656 |
| Product Code | PBY |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2013-02-04 |
| Summary: | summary |