510(k) K811493
K811493 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "CRUTCH & WALKER PADS". The FDA issued a decision of Substantially Equivalent on Jun 12, 1981. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790. Fred Sammons, Inc. has 277 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 1981
- Date Received
- May 26, 1981
- 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