The following data is part of a premarket notification filed by Imed Corp. with the FDA for Iv Filterset 0.22 Micrometer.
| Device ID | K813446 |
| 510k Number | K813446 |
| Device Name: | IV FILTERSET 0.22 MICROMETER |
| Classification | Filter, Infusion Line |
| Applicant | IMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-09 |
| Decision Date | 1982-01-05 |