The following data is part of a premarket notification filed by Helio Medical Supplies, Inc. with the FDA for Acumaster Brand Acupuncture Needle.
| Device ID | K991508 |
| 510k Number | K991508 |
| Device Name: | ACUMASTER BRAND ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HELIO MEDICAL SUPPLIES, INC. 2080A WALSH AVE. Santa Clara, CA 95050 |
| Contact | Yi-fen Chang |
| Correspondent | Yi-fen Chang HELIO MEDICAL SUPPLIES, INC. 2080A WALSH AVE. Santa Clara, CA 95050 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-29 |
| Decision Date | 1999-08-27 |