The following data is part of a premarket notification filed by Swiss American Products, Inc. with the FDA for Eutra Gel For Wound Dressing.
| Device ID | K932291 |
| 510k Number | K932291 |
| Device Name: | EUTRA GEL FOR WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SWISS AMERICAN PRODUCTS, INC. 4315 ALPHA RD. Dallas, TX 75244 |
| Contact | Eugene Stubbs |
| Correspondent | Eugene Stubbs SWISS AMERICAN PRODUCTS, INC. 4315 ALPHA RD. Dallas, TX 75244 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1994-07-18 |