510(k) K902320
K902320 is an FDA 510(k) premarket notification submitted by Proact, Ltd. for the device "BAUER FLEXI-TEMNO BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on Oct 1, 1990. The device falls under product code FCG (Biopsy Needle), 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
- Oct 1, 1990
- Date Received
- May 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type
- 510(k)