510(k) K890085
K890085 is an FDA 510(k) premarket notification submitted by Drummond Industries, Inc. for the device "SIT-N-BATHE SITZ BATH". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code KTC (Bath, Sitz, Nonpowered), a Class I device regulated under 21 CFR 890.5125.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1989
- Date Received
- January 10, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Sitz, Nonpowered
- Device Class
- Class I
- Regulation Number
- 890.5125
- Review Panel
- PM
- Submission Type