K991559 is an FDA 510(k) clearance for the MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 23, 1999, 111 days after receiving the submission on May 4, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K991559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1999 |
| Decision Date | August 23, 1999 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |