510(k) K896580
K896580 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "UNI-POLAR HEAD". The FDA issued a decision of Substantially Equivalent on February 15, 1990. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 1990
- Date Received
- November 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type