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 |