K881707 is an FDA 510(k) clearance for the INTROCULAR FLUID INJECTOR. This device is classified as a Pump, Infusion Or Syringe, Extra-luminal (Class II - Special Controls, product code FIH).
Submitted by B&B Medical Assoc., Inc. (Danvers, US). The FDA issued a Cleared decision on October 21, 1988, 193 days after receiving the submission on April 11, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K881707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1988 |
| Decision Date | October 21, 1988 |
| Days to Decision | 193 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 |