The following data is part of a premarket notification filed by Autovage with the FDA for Irrivage.
| Device ID | K922785 |
| 510k Number | K922785 |
| Device Name: | IRRIVAGE |
| Classification | Protector, Wound, Plastic |
| Applicant | AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
| Contact | Joseph P Rudolph |
| Correspondent | Joseph P Rudolph AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
| Product Code | EYF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1992-10-16 |