K090199 is an FDA 510(k) clearance for the JIAJIAN ACUPUNCTURE NEEDLE. This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 11, 2009, 196 days after receiving the submission on January 27, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K090199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2009 |
| Decision Date | August 11, 2009 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MQX - Needle, Acupuncture, Single Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5580 |