510(k) K951421
K951421 is an FDA 510(k) premarket notification submitted by Global Medical Products, Ltd. for the device "GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES". The FDA issued a decision of Substantially Equivalent on November 16, 1995. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Global Medical Products, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1995
- Date Received
- March 28, 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