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 |