510(k) K895420
K895420 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "SUCTION BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on Feb 9, 1990. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Mill-Rose Laboratory has 45 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 1990
- Date Received
- Sep 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Suction
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type
- 510(k)