510(k) K912179
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1991
- Date Received
- May 16, 1991
- 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