The following data is part of a premarket notification filed by Maeda Toyokichi Shoten with the FDA for Maeda New Needle Disposable.
| Device ID | K000581 |
| 510k Number | K000581 |
| Device Name: | MAEDA NEW NEEDLE DISPOSABLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | MAEDA TOYOKICHI SHOTEN P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith MAEDA TOYOKICHI SHOTEN P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2001-02-23 |