The following data is part of a premarket notification filed by Setma, Inc. with the FDA for Setma Hygia Bath Model St 7200.
| Device ID | K854861 |
| 510k Number | K854861 |
| Device Name: | SETMA HYGIA BATH MODEL ST 7200 |
| Classification | Bath, Hydro-massage |
| Applicant | SETMA, INC. Whitehouse, NJ 08888 |
| Contact | Richard B Dardas |
| Correspondent | Richard B Dardas SETMA, INC. Whitehouse, NJ 08888 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-05 |
| Decision Date | 1986-01-03 |