510(k) K851798
K851798 is an FDA 510(k) premarket notification submitted by Artiberia for the device "53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1985
- Date Received
- Apr 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)