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 |