510(k) K931194
K931194 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "CO-CR ANSWER FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on May 5, 1994. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1994
- Date Received
- March 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type