K880613 is an FDA 510(k) clearance for the ACCO(R) FACE MASK. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Absorbent Cotton Co., Inc. (Hammonton, US). The FDA issued a Cleared decision on March 4, 1988, 17 days after receiving the submission on February 16, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K880613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1988 |
| Decision Date | March 04, 1988 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |