K962035 is an FDA 510(k) clearance for the GE STERILE ARTHROGRAM TRAY. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by GE Medical Systems (Tarpon Springs, US). The FDA issued a Cleared decision on June 25, 1996, 32 days after receiving the submission on May 24, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K962035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1996 |
| Decision Date | June 25, 1996 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |