510(k) K941256
K941256 is an FDA 510(k) premarket notification submitted by Proact, Ltd. for the device "QUICK CORE II". The FDA issued a decision of Substantially Equivalent on Jul 13, 1994. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Proact, Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 1994
- Date Received
- Mar 14, 1994
- 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)