The following data is part of a premarket notification filed by Wujiang City Hua Xin Medical Appliance Co., Ltd. with the FDA for Holy Dragon Brand Acupuncture Needles.
| Device ID | K021095 |
| 510k Number | K021095 |
| Device Name: | HOLY DRAGON BRAND ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. 10 WESTMONT RD. Candler, NC 28715 |
| Contact | Laura J Thorne |
| Correspondent | Laura J Thorne WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. 10 WESTMONT RD. Candler, NC 28715 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2002-05-17 |
| Summary: | summary |