The following data is part of a premarket notification filed by Wujiang City Shenli Medical And Health Material Co with the FDA for Qizhou Acupuncture Needle.
| Device ID | K013926 |
| 510k Number | K013926 |
| Device Name: | QIZHOU ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO 503 ROOM, 8 BUILDING, 600 LIU ZHON ROAD Shanghi, CN 200233 |
| Contact | Gong Bo |
| Correspondent | Gong Bo WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO 503 ROOM, 8 BUILDING, 600 LIU ZHON ROAD Shanghi, CN 200233 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-28 |
| Decision Date | 2002-07-18 |