The following data is part of a premarket notification filed by Repro-med Systems, Inc. with the FDA for Rms Subcutaneous Needle Set.
| Device ID | K102512 |
| 510k Number | K102512 |
| Device Name: | RMS SUBCUTANEOUS NEEDLE SET |
| Classification | Set, Administration, Intravascular |
| Applicant | REPRO-MED SYSTEMS, INC. 24 CARPENTER RD. Chester, NY 10918 |
| Contact | Andrew Sealfon |
| Correspondent | Andrew Sealfon REPRO-MED SYSTEMS, INC. 24 CARPENTER RD. 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 | 2010-09-01 |
| Decision Date | 2011-05-20 |
| Summary: | summary |