The following data is part of a premarket notification filed by Cardia Innovation Ab with the FDA for Carbonaid C02 Diffuser.
| Device ID | K112975 |
| 510k Number | K112975 |
| Device Name: | CARBONAID C02 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 | 2011-10-05 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27340026114006 | K112975 | 000 |
| 27340026100023 | K112975 | 000 |