510(k) K833403
K833403 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "BDH UNIPOLAR FEMORAL COMPONENT A2". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1984
- Date Received
- September 30, 1983
- 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