510(k) K915776
K915776 is an FDA 510(k) premarket notification submitted by Kim-Med, Inc. for the device "KNEE PROSTHESIS DRIVER". The FDA issued a decision of Substantially Equivalent on Jun 11, 1992. The device falls under product code HWR (Driver, Prosthesis), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 1992
- Date Received
- Dec 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Prosthesis
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type