510(k) K830285
K830285 is an FDA 510(k) premarket notification submitted by Besco Financial Service for the device "REGNELL HYDRAULIC FEMORAL PROTHESIS". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External), a Class II device regulated under 21 CFR 890.3500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1983
- Date Received
- January 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assembly, Thigh/Knee/Shank/Ankle/Foot, External
- Device Class
- Class II
- Regulation Number
- 890.3500
- Review Panel
- PM
- Submission Type