The following data is part of a premarket notification filed by Helio Medical Supplies, Inc. with the FDA for Press Tack/intradermal Acupuncture Needles.
| Device ID | K050295 |
| 510k Number | K050295 |
| Device Name: | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Contact | Eric Cheng |
| Correspondent | Eric Cheng HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-25 |