K893417 is an FDA 510(k) clearance for the SURGIFRESH SUB-MICRON MASK NO. 901008-000. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Texas Medical Products, Inc. (The Woodlands, US). The FDA issued a Cleared decision on June 22, 1989, 51 days after receiving the submission on May 2, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K893417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1989 |
| Decision Date | June 22, 1989 |
| Days to Decision | 51 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 |