The following data is part of a premarket notification filed by Haenglim Seowon Corp. with the FDA for Mac Acupuncture Needle.
| Device ID | K002827 |
| 510k Number | K002827 |
| Device Name: | MAC ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HAENGLIM SEOWON CORP. 34-69 LEAVITT ST. Flushing, NY 11354 |
| Contact | Yun Chol Cho |
| Correspondent | Yun Chol Cho HAENGLIM SEOWON CORP. 34-69 LEAVITT ST. Flushing, NY 11354 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-11 |
| Decision Date | 2001-02-28 |