510(k) K030205
K030205 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "CONSENSUS UNIPOLAR HEAD, COCR". The FDA issued a decision of Substantially Equivalent on April 1, 2003. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2003
- Date Received
- January 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type