The following data is part of a premarket notification filed by Allergy Laboratories Of Ohio, Inc. with the FDA for Bifurcated Needle.
| Device ID | K874249 |
| 510k Number | K874249 |
| Device Name: | BIFURCATED NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ALLERGY LABORATORIES OF OHIO, INC. 623 E. 11TH AVE. Columbus, OH 43211 |
| Contact | Michael Koehler |
| Correspondent | Michael Koehler ALLERGY LABORATORIES OF OHIO, INC. 623 E. 11TH AVE. Columbus, OH 43211 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-11-03 |