The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primagard Yellow Surgical Mask, Pleated, Tie-on, Pm4-307; Primagard Yellow Surgical Mask, Pleated, Ear-loop,pm4-308; Prm.
| Device ID | K021076 |
| 510k Number | K021076 |
| Device Name: | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM |
| Classification | Mask, Surgical |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 10707-100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Contact | Brenda Lee |
| Correspondent | Brenda Lee PRIMELINE MEDICAL PRODUCTS, INC. 10707-100TH AVE., SUITE 300 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 | 2002-04-03 |
| Decision Date | 2002-04-16 |