The following data is part of a premarket notification filed by K.s. Choi Corp. with the FDA for Acupuncture Needles.
| Device ID | K961677 |
| 510k Number | K961677 |
| Device Name: | ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | K.S. CHOI CORP. 3932 WILSHIRE BLVD., #300 Los Angeles, CA 90010 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-10-28 |