The following data is part of a premarket notification filed by K.s. Choi Corporation with the FDA for Acuzone Acupuncture Needles, Ksc Db Plus Acupuncture Needles.
| Device ID | K142760 |
| 510k Number | K142760 |
| Device Name: | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | K.S. Choi Corporation 179 W39th St Los Angeles, CA 90037 |
| Contact | Kak Soo Choi |
| Correspondent | Kak Soo Choi K.S. Choi Corporation 179 W 39th St Los Angeles, CA 90037 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-25 |
| Decision Date | 2015-08-25 |
| Summary: | summary |