510(k) K851788
K851788 is an FDA 510(k) premarket notification submitted by Artiberia for the device "29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES,". The FDA issued a decision of Substantially Equivalent on Jun 20, 1985. The device falls under product code FZO (Chisel, Surgical, Manual), a Class I device regulated under 21 CFR 878.4800. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 1985
- Date Received
- Apr 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Chisel, Surgical, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt