The following data is part of a premarket notification filed by Medafor, Inc. with the FDA for Medafor Direct Gas-assisted Application System.
| Device ID | K123325 |
| 510k Number | K123325 |
| Device Name: | Medafor Direct Gas-Assisted Application System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDAFOR, INC. 2700 FREEWAY BLVD SUITE 800 Minneapolis, MN 55430 |
| Contact | Melissa Young |
| Correspondent | Melissa Young MEDAFOR, INC. 2700 FREEWAY BLVD SUITE 800 Minneapolis, MN 55430 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-01-24 |
| Summary: | summary |