The following data is part of a premarket notification filed by Harbor Medical Devices, Inc. with the FDA for Hypodermic Needles, Single Lumen.
| Device ID | K874414 |
| 510k Number | K874414 |
| Device Name: | HYPODERMIC NEEDLES, SINGLE LUMEN |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston, MA 02210 -3912 |
| Contact | Joshua Tolkoff |
| Correspondent | Joshua Tolkoff HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston, MA 02210 -3912 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-01-14 |