The following data is part of a premarket notification filed by Acusupply, Inc. with the FDA for Holy Dragon Sterile Acupuncture Needle For Single Use.
| Device ID | K011247 |
| 510k Number | K011247 |
| Device Name: | HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | ACUSUPPLY, INC. 3801 NE 207TH ST., SUITE 501 Aventura, FL 33180 |
| Contact | Feres Dager |
| Correspondent | Feres Dager ACUSUPPLY, INC. 3801 NE 207TH ST., SUITE 501 Aventura, FL 33180 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-10-17 |