The following data is part of a premarket notification filed by Mandala Health Care, Llc with the FDA for Jia Chen Acupuncture Needle, For Single Use.
| Device ID | K023054 |
| 510k Number | K023054 |
| Device Name: | JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | MANDALA HEALTH CARE, LLC 4320 SPRING VALLEY RD., Dallas, TX 75244 -4352 |
| Contact | Dashima Dovchin |
| Correspondent | Dashima Dovchin MANDALA HEALTH CARE, LLC 4320 SPRING VALLEY RD., Dallas, TX 75244 -4352 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-13 |
| Decision Date | 2002-11-13 |
| Summary: | summary |