The following data is part of a premarket notification filed by Primed Medical Products Inc. with the FDA for Primagard Delta Fit 80,120, 160 Surgical Face Mask (small, Medium, Large) Model Pg4-7061,-7071,-7081, Pg4-7062, 7072-70.
| Device ID | K092012 |
| 510k Number | K092012 |
| Device Name: | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 |
| Classification | Mask, Surgical |
| Applicant | PRIMED MEDICAL PRODUCTS INC. SUITE 900, 10707-100 AVE. Edmonton, Alberta, CA T5j 3m1 |
| Contact | Raymond Marusyk |
| Correspondent | Raymond Marusyk PRIMED MEDICAL PRODUCTS INC. SUITE 900, 10707-100 AVE. Edmonton, Alberta, CA T5j 3m1 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-09-25 |
| Summary: | summary |