The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Vial Decanter.
| Device ID | K111577 |
| 510k Number | K111577 |
| Device Name: | MEDLINE VIAL DECANTER |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-07 |
| Decision Date | 2011-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942692682 | K111577 | 000 |
| 40889942499282 | K111577 | 000 |