The following data is part of a premarket notification filed by Haenglim Seowon Medical Co. with the FDA for Acupuncture Needles.
| Device ID | K092240 |
| 510k Number | K092240 |
| Device Name: | ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HAENGLIM SEOWON MEDICAL CO. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith HAENGLIM SEOWON MEDICAL CO. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2010-04-21 |
| Summary: | summary |