| Device Type ID | 2685 |
| Device Name | Needle, Acupuncture, Single Use |
| Regulation Description | Acupuncture Needle. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MQX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2685 |
| Device | Needle, Acupuncture, Single Use |
| Product Code | MQX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Acupuncture Needle. |
| CFR Regulation Number | 880.5580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMC INTL., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |