The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Sitz Bath.
| Device ID | K841711 |
| 510k Number | K841711 |
| Device Name: | MAC LEE SITZ BATH |
| Classification | Bath, Sitz, Nonpowered |
| Applicant | MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTC |
| CFR Regulation Number | 890.5125 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-24 |
| Decision Date | 1984-05-07 |