The following data is part of a premarket notification filed by Lsl Industries, Inc. with the FDA for Sitz Bath, Single Patient Use #8100.
| Device ID | K831762 |
| 510k Number | K831762 |
| Device Name: | SITZ BATH, SINGLE PATIENT USE #8100 |
| Classification | Bath, Sitz, Nonpowered |
| Applicant | LSL INDUSTRIES, INC. 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 | 1983-06-01 |
| Decision Date | 1983-06-24 |