510(k) K894604
K894604 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT". The FDA issued a decision of SN on November 17, 1989. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Biopro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 17, 1989
- Date Received
- July 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Femoral, Resurfacing
- Device Class
- Class II
- Regulation Number
- 888.3400
- Review Panel
- OR
- Submission Type