The following data is part of a premarket notification filed by Maeda Toyokichi Shoten with the FDA for Maeda Silver Acupuncture Needle.
| Device ID | K021904 |
| 510k Number | K021904 |
| Device Name: | MAEDA SILVER ACUPUNCTURE NEEDLE |
| 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 | 2002-06-10 |
| Decision Date | 2002-08-14 |