The following data is part of a premarket notification filed by Cardiomed Supplies, Inc. with the FDA for Noncor Infusion Sets; Noncor Port Infusion Sets.
| Device ID | K021080 |
| 510k Number | K021080 |
| Device Name: | NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario, CA L0h 1g0 |
| Contact | Donna Mccomb |
| Correspondent | Donna Mccomb CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario, CA L0h 1g0 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-03 |
| Decision Date | 2002-08-29 |