The following data is part of a premarket notification filed by Marknew Products with the FDA for Acupuncture Needles.
| Device ID | K043506 |
| 510k Number | K043506 |
| Device Name: | ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | MARKNEW PRODUCTS 3722 AVE, SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland MARKNEW PRODUCTS 3722 AVE, SAUSALITO Irvine, CA 92606 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-02-11 |