The following data is part of a premarket notification filed by Global Medical Products, Ltd. with the FDA for Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene Needles.
| Device ID | K951421 |
| 510k Number | K951421 |
| Device Name: | GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES |
| Classification | Biopsy Needle |
| Applicant | GLOBAL MEDICAL PRODUCTS, LTD. 2230 NURSERY RD. UNIT D41 Clearwater, FL 34624 |
| Contact | Donald Ryan |
| Correspondent | Donald Ryan GLOBAL MEDICAL PRODUCTS, LTD. 2230 NURSERY RD. UNIT D41 Clearwater, FL 34624 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-28 |
| Decision Date | 1995-11-16 |