The following data is part of a premarket notification filed by Global Medical Products, Ltd. with the FDA for Global Medical Products Brest Lesion Localization Needle With Stiffened Wire.
| Device ID | K950311 |
| 510k Number | K950311 |
| Device Name: | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE |
| Classification | Guide, Needle, Surgical |
| Applicant | GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Contact | Peter Clark |
| Correspondent | Peter Clark GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-16 |
| Decision Date | 1995-05-26 |