The following data is part of a premarket notification filed by Shenling Medical Device Co., Ltd with the FDA for Shenling Acupuncture Needles.
| Device ID | K002411 |
| 510k Number | K002411 |
| Device Name: | SHENLING ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SHENLING MEDICAL DEVICE CO., LTD 1800 CENTURY PARK EAST SUITE 600 Los Angeles, CA 90067 -1509 |
| Contact | George Su |
| Correspondent | George Su SHENLING MEDICAL DEVICE CO., LTD 1800 CENTURY PARK EAST SUITE 600 Los Angeles, CA 90067 -1509 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-12-12 |