K873957 is an FDA 510(k) clearance for the NON-CORING HUBER TYPE NEEDLES. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Advantage Medical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on October 23, 1987, 25 days after receiving the submission on September 28, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K873957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1987 |
| Decision Date | October 23, 1987 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |