K914872 is an FDA 510(k) clearance for the MARLOW SUCTION/IRRIGATION PROBES. This device is classified as a Antiserum, Fluorescent, Francisella Tularensis (Class II - Special Controls, product code GSJ).
Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on November 19, 1991, 21 days after receiving the submission on October 29, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3280.
| 510(k) Number | K914872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1991 |
| Decision Date | November 19, 1991 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GSJ — Antiserum, Fluorescent, Francisella Tularensis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3280 |