The following data is part of a premarket notification filed by The Healthcare Group Laboratories, Inc. with the FDA for Personal Sitz Bath Kit.
| Device ID | K800958 |
| 510k Number | K800958 |
| Device Name: | PERSONAL SITZ BATH KIT |
| Classification | Bath, Sitz, Nonpowered |
| Applicant | THE HEALTHCARE GROUP LABORATORIES, INC. MD |
| Product Code | KTC |
| CFR Regulation Number | 890.5125 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-23 |
| Decision Date | 1980-05-02 |