The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Cianna Medical Permanent Tissue Marker And Delivery System.
| Device ID | K132463 |
| 510k Number | K132463 |
| Device Name: | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM |
| Classification | Marker, Radiographic, Implantable |
| 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 | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-12-03 |
| Summary: | summary |