510(k) K843522
K843522 is an FDA 510(k) premarket notification submitted by Australian Biomedical Corporation , Ltd. for the device "DONWAY SPLINT". The FDA issued a decision of Substantially Equivalent on February 7, 1985. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Australian Biomedical Corporation , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1985
- Date Received
- September 7, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type