510(k) K951598
K951598 is an FDA 510(k) premarket notification submitted by Promedical , Ltd. for the device "PRO-B BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on April 21, 1995. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Promedical , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1995
- Date Received
- April 7, 1995
- 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