510(k) K082705
K082705 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO BIPOLAR HEAD, MODELS 18130-18152". The FDA issued a decision of Substantially Equivalent on December 15, 2008. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Biopro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2008
- Date Received
- September 16, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3390
- Review Panel
- OR
- Submission Type