510(k) K934253
K934253 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "EXACTECH ALL POLY ACETABULAR CUP". The FDA issued a decision of Substantially Equivalent on April 29, 1994. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Exactech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1994
- Date Received
- August 31, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Cement, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 888.4210
- Review Panel
- OR
- Submission Type