K960769 is an FDA 510(k) clearance for the ACUPUNCTURE NEEDLE PACK. This device is classified as a Needle, Acupuncture, Single Use (Class II - Special Controls, product code MQX).
Submitted by Acu Med, Inc. (Burbank, US). The FDA issued a Cleared decision on July 10, 1996, 135 days after receiving the submission on February 26, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5580.
| 510(k) Number | K960769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1996 |
| Decision Date | July 10, 1996 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MQX — Needle, Acupuncture, Single Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5580 |