510(k) K831889
K831889 is an FDA 510(k) premarket notification submitted by W.K. Wheeler, Inc. for the device "SURGEON'S CHOICE CRUTCH HANDLE". The FDA issued a decision of Substantially Equivalent on Jul 7, 1983. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 1983
- Date Received
- Jun 14, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tips And Pads, Cane, Crutch And Walker
- Device Class
- Class I
- Regulation Number
- 890.3790
- Review Panel
- PM
- Submission Type
- 510(k) Exempt