K092012 is an FDA 510(k) clearance for the PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Primed Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on September 25, 2009, 81 days after receiving the submission on July 6, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K092012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2009 |
| Decision Date | September 25, 2009 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |