K900439 is an FDA 510(k) clearance for the SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC. This device is classified as a Pump, Infusion Or Syringe, Extra-luminal (Class II - Special Controls, product code FIH).
Submitted by L H M Ent., Inc. (Indian Mills, US). The FDA issued a Cleared decision on February 15, 1990, 17 days after receiving the submission on January 29, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K900439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1990 |
| Decision Date | February 15, 1990 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIH — Pump, Infusion Or Syringe, Extra-luminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |