510(k) K831762
K831762 is an FDA 510(k) premarket notification submitted by Lsl Industries, Inc. for the device "SITZ BATH, SINGLE PATIENT USE #8100". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code KTC (Bath, Sitz, Nonpowered), a Class I device regulated under 21 CFR 890.5125. Lsl Industries, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1983
- Date Received
- June 1, 1983
- 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