510(k) K810228
K810228 is an FDA 510(k) premarket notification submitted by Hamilton Kent for the device "SORBOTHANE". The FDA issued a decision of Substantially Equivalent on February 10, 1981. 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 10, 1981
- Date Received
- January 27, 1981
- 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