510(k) K862600
K862600 is an FDA 510(k) premarket notification submitted by W. C. Green, D.D.S. for the device "SITZ BATH". The FDA issued a decision of Substantially Equivalent on July 18, 1986. 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
- July 18, 1986
- Date Received
- July 8, 1986
- 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