The following data is part of a premarket notification filed by H F Intl. Co. with the FDA for Bw Acupuncture Needles.
| Device ID | K011669 |
| 510k Number | K011669 |
| Device Name: | BW ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | H F INTL. CO. 865 SOUTH FIGUEROA ST. SUITE 2308 Los Angeles, CA 90017 |
| Contact | John N Politis |
| Correspondent | John N Politis H F INTL. CO. 865 SOUTH FIGUEROA ST. SUITE 2308 Los Angeles, CA 90017 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-07-09 |