The following data is part of a premarket notification filed by Setma, Inc. with the FDA for Burn Bath.
| Device ID | K841397 |
| 510k Number | K841397 |
| Device Name: | BURN BATH |
| Classification | Bath, Hydro-massage |
| Applicant | SETMA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-05-18 |