510(k) K890285
K890285 is an FDA 510(k) premarket notification submitted by Albert K. Chin for the device "PROSTHETIC CEMENT REMOVER". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code LZV (System, Cement Removal Extraction), a Class II device regulated under 21 CFR 888.4580.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1989
- Date Received
- January 19, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cement Removal Extraction
- Device Class
- Class II
- Regulation Number
- 888.4580
- Review Panel
- OR
- Submission Type