MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
FDA 510(k) clearance K122404 · decided 2013-05-06
Clearance details
- K-number
- K122404
- Device name
- MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
- Applicant
- Repro-Med Systems, Inc. Dba Rms Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2012-08-07
- Decision date
- 2013-05-06
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Num recall (Z-0318-2018) | Repro-Med Systems, Inc. | 2018-01-05 |