510(k) K790326
K790326 is an FDA 510(k) premarket notification submitted by J.E. Hanger & Co. , Ltd. for the device "DRUSHOE". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code KNP (Orthosis, Corrective Shoe), a Class I device regulated under 21 CFR 890.3475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1979
- Date Received
- February 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Corrective Shoe
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type