The following data is part of a premarket notification filed by Primed Medical Products Inc. with the FDA for Primagard 80, 120, 160 Fluid Resistant Procedure/surgical Face Masks.
| Device ID | K081633 |
| 510k Number | K081633 |
| Device Name: | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS |
| Classification | Mask, Surgical |
| Applicant | PRIMED MEDICAL PRODUCTS INC. SUITE 900, 10707-100 AVE. Edmonton, Alberta, CA T5j 3m1 |
| Contact | Raymond G Marusyk |
| Correspondent | Raymond G 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 | 2008-06-11 |
| Decision Date | 2008-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20890022201 | K081633 | 000 |
| M20890022191 | K081633 | 000 |
| M20890022181 | K081633 | 000 |
| M20890022171 | K081633 | 000 |
| M20890022161 | K081633 | 000 |
| M20890022151 | K081633 | 000 |
| M20890022141 | K081633 | 000 |
| M20890022131 | K081633 | 000 |