The following data is part of a premarket notification filed by Acu-med, Inc. with the FDA for Acupuncture Needle Pack.
| Device ID | K960769 |
| 510k Number | K960769 |
| Device Name: | ACUPUNCTURE NEEDLE PACK |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | ACU-MED, INC. 2701 WEST ALAMEDA AVE., #301 Burbank, CA 91505 |
| Contact | Jeung H Choi, M.d. |
| Correspondent | Jeung H Choi, M.d. ACU-MED, INC. 2701 WEST ALAMEDA AVE., #301 Burbank, CA 91505 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-07-10 |