The following data is part of a premarket notification filed by United Pacific Co., Ltd. with the FDA for Millennia Acupuncture Needle.
Device ID | K001718 |
510k Number | K001718 |
Device Name: | MILLENNIA ACUPUNCTURE NEEDLE |
Classification | Needle, Acupuncture, Single Use |
Applicant | UNITED PACIFIC CO., LTD. 219 SOUTH RAYMOND AVE. Alhambra, CA 91801 |
Contact | Daniel Ye Hua |
Correspondent | Daniel Ye Hua UNITED PACIFIC CO., LTD. 219 SOUTH RAYMOND AVE. Alhambra, CA 91801 |
Product Code | MQX |
CFR Regulation Number | 880.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-05 |
Decision Date | 2000-06-21 |