The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Blood Collection Set.
Device ID | K170002 |
510k Number | K170002 |
Device Name: | Medline Blood Collection Set |
Classification | Set, Administration, Intravascular |
Applicant | Medline Industries, Inc. One Medline Place Mundelein, IL 60060 |
Contact | Matt Clausen |
Correspondent | Matt Clausen Medline Industries, Inc. One Medline Place 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 | 2017-01-03 |
Decision Date | 2017-09-19 |