The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Hypodermic Needles.
| Device ID | K062984 |
| 510k Number | K062984 |
| Device Name: | MEDLINE HYPODERMIC NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2006-11-13 |