The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primed Pleated Tie-back, Procedure Mask Pm4-305, Primed Pleated Ear-loop, Procedure Mask Pm4-306.
| Device ID | K001951 |
| 510k Number | K001951 |
| Device Name: | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 |
| Classification | Mask, Surgical |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 10707 100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Contact | Katherine Co |
| Correspondent | Katherine Co 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2000-09-08 |