The following data is part of a premarket notification filed by Cardia Innovation Ab with the FDA for Carbonaid Gas Diffuser.
| Device ID | K052125 |
| 510k Number | K052125 |
| Device Name: | CARBONAID GAS DIFFUSER |
| Classification | Insufflator, Laparoscopic |
| Applicant | CARDIA INNOVATION AB 7307 GLOCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman CARDIA INNOVATION AB 7307 GLOCHESTER DRIVE Edina, MN 55435 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2006-02-08 |
| Summary: | summary |