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 |