The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Lo-profile Extensionset W/ .22 Micron Filter.
| Device ID | K925430 |
| 510k Number | K925430 |
| Device Name: | LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER |
| Classification | Set, Administration, Intravascular |
| Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
| Contact | Douglas Johnson |
| Correspondent | Douglas Johnson DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-27 |
| Decision Date | 1993-08-03 |