K950311 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE. This device is classified as a Guide, Needle, Surgical (Class I - General Controls, product code GDF).
Submitted by Global Medical Products, Ltd. (Woodbury, US). The FDA issued a Cleared decision on May 26, 1995, 130 days after receiving the submission on January 16, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K950311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1995 |
| Decision Date | May 26, 1995 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |