The following data is part of a premarket notification filed by Changchun Aik Medical Devices Co., Ltd with the FDA for Aik Sterile Acupuncture Needles For Single Use.
| Device ID | K162566 |
| 510k Number | K162566 |
| Device Name: | AIK Sterile Acupuncture Needles For Single Use |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | CHANGCHUN AIK MEDICAL DEVICES CO., LTD NO. 25, KAREN INDUSTRIAL PARK, JIUTAI ECONOMIC DEVELOPMENT ZONE Changchun, CN 130507 |
| Contact | Xingwang Li |
| Correspondent | Xingwang Li CHANGCHUN AIK MEDICAL DEVICES CO., LTD NO. 25, KAREN INDUSTRIAL PARK, JIUTAI ECONOMIC DEVELOPMENT ZONE Changchun, CN 130507 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-05-11 |
| Summary: | summary |