The following data is part of a premarket notification filed by Concert Medical, Llc with the FDA for Concert Medical Hands-free Syringe (hfs).
| Device ID | K153599 |
| 510k Number | K153599 |
| Device Name: | Concert Medical Hands-Free Syringe (HFS) |
| Classification | Pump, Infusion |
| Applicant | Concert Medical, LLC 77 Accord Park Drive Norwell, MA 02061 |
| Contact | Timothy S Powers |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850316008036 | K153599 | 000 |
| 00850316008029 | K153599 | 000 |
| 00850316008012 | K153599 | 000 |
| 35060727270038 | K153599 | 000 |
| 05060727270020 | K153599 | 000 |
| 05060727270013 | K153599 | 000 |
| 35060727270052 | K153599 | 000 |
| 05060727270068 | K153599 | 000 |