The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Cianna Medical Sgs System.
| Device ID | K141318 |
| 510k Number | K141318 |
| Device Name: | CIANNA MEDICAL SGS SYSTEM |
| Classification | Internal Tissue Marker |
| Applicant | CIANNA MEDICAL, INC. 6 JOURNEY, SUITE 125 Aliso Vijeo, CA 92656 |
| Contact | Gary Moncnik |
| Correspondent | Gary Mocnik CIANNA MEDICAL, INC. 6 JOURNEY, SUITE 125 Aliso Vijeo, CA 92656 |
| Product Code | PDW |
| CFR Regulation Number | 878.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-08-27 |