510(k) K800076
K800076 is an FDA 510(k) premarket notification submitted by New World Imports, Inc. for the device "CRUTCH TIPS, PADS & HAND GRIPS". The FDA issued a decision of Substantially Equivalent on January 28, 1980. 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
- January 28, 1980
- Date Received
- January 14, 1980
- 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