The following data is part of a premarket notification filed by Repro-med Systems, Inc. Dba Rms Medical Products with the FDA for High-flo Super26 Subcutaneous Needle Sets.
| Device ID | K180843 |
| 510k Number | K180843 |
| Device Name: | HIgH-Flo Super26 Subcutaneous Needle Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Repro-Med Systems, Inc. Dba RMS Medical Products 24 Carpenter Road Chester, NY 10918 |
| Contact | Fred Ma |
| Correspondent | Cynthia Lacatena Repro-Med Systems, Inc. Dba RMS Medical Products 24 Carpenter Road Chester, NY 10918 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2019-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10659443003078 | K180843 | 000 |
| 10659443002910 | K180843 | 000 |
| 10659443002903 | K180843 | 000 |
| 00659443002890 | K180843 | 000 |
| 00659443002883 | K180843 | 000 |
| 00659443002876 | K180843 | 000 |
| 00659443002845 | K180843 | 000 |
| 10659443002828 | K180843 | 000 |
| 10659443002811 | K180843 | 000 |
| 10659443002804 | K180843 | 000 |
| 10659443002798 | K180843 | 000 |
| 10659443002781 | K180843 | 000 |
| 10659443002866 | K180843 | 000 |
| 10659443002835 | K180843 | 000 |
| 10659443002927 | K180843 | 000 |
| 10659443002934 | K180843 | 000 |
| 10659443003061 | K180843 | 000 |
| 10659443003054 | K180843 | 000 |
| 10659443003047 | K180843 | 000 |
| 10659443003030 | K180843 | 000 |
| 10659443003023 | K180843 | 000 |
| 10659443003016 | K180843 | 000 |
| 10659443003009 | K180843 | 000 |
| 10659443002996 | K180843 | 000 |
| 10659443002989 | K180843 | 000 |
| 10659443002972 | K180843 | 000 |
| 10659443002965 | K180843 | 000 |
| 10659443002958 | K180843 | 000 |
| 10659443002941 | K180843 | 000 |
| 10659443002859 | K180843 | 000 |