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 |