510(k) K851205
K851205 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "CEMENTRIFUGE". The FDA issued a decision of Substantially Equivalent on July 16, 1985. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1985
- Date Received
- March 26, 1985
- 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