510(k) K923880
K923880 is an FDA 510(k) premarket notification submitted by Mopac, Ltd. for the device "ORLAU SWIVEL WALKER". The FDA issued a decision of Substantially Equivalent on September 30, 1996. The device falls under product code MRI (Orthosis, Truncal/Orthosis, Limb), a Class I device regulated under 21 CFR 890.3490.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1996
- Date Received
- July 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Truncal/Orthosis, Limb
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type