The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd. with the FDA for Jiajian Acupuncture Needle.
| Device ID | K090199 |
| 510k Number | K090199 |
| Device Name: | JIAJIAN ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu, CN 214116 |
| Contact | Doris Dong |
| Correspondent | Doris Dong WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu, CN 214116 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2009-08-11 |
| Summary: | summary |