The following data is part of a premarket notification filed by Scientific Health Care with the FDA for Acupuncture Needle Under The Brand Name Hwato And Huaxia.
| Device ID | K974122 |
| 510k Number | K974122 |
| Device Name: | ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SCIENTIFIC HEALTH CARE 1491 BAKER STREET, SUITE 1 Costa Mesa, CA 92626 |
| Contact | Henry Woo |
| Correspondent | Henry Woo SCIENTIFIC HEALTH CARE 1491 BAKER STREET, SUITE 1 Costa Mesa, CA 92626 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-01-22 |