The following data is part of a premarket notification filed by Drummond Industries, Inc. with the FDA for Sit-n-bathe Sitz Bath.
| Device ID | K890085 | 
| 510k Number | K890085 | 
| Device Name: | SIT-N-BATHE SITZ BATH | 
| Classification | Bath, Sitz, Nonpowered | 
| Applicant | DRUMMOND INDUSTRIES, INC. 1453 ETNA AVE. Huntington, IN 46750 | 
| Contact | E Drummond | 
| Correspondent | E Drummond DRUMMOND INDUSTRIES, INC. 1453 ETNA AVE. Huntington, IN 46750 | 
| Product Code | KTC | 
| CFR Regulation Number | 890.5125 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1989-01-10 | 
| Decision Date | 1989-02-13 |