The following data is part of a premarket notification filed by Dmc Medical Ltd. with the FDA for Dmc Medical Single-use Polycarbonate Syringe.
| Device ID | K103736 |
| 510k Number | K103736 |
| Device Name: | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | DMC MEDICAL LTD. 944 NORTH MAIN STREET Bountiful, UT 84010 |
| Contact | Tracy Best |
| Correspondent | Tracy Best DMC MEDICAL LTD. 944 NORTH MAIN STREET Bountiful, UT 84010 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2011-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1605020Y1 | K103736 | 000 |
| 40193489954242 | K103736 | 000 |
| G002100630 | K103736 | 000 |
| G002100170 | K103736 | 000 |
| G002100350 | K103736 | 000 |
| G002100360 | K103736 | 000 |
| G001ZSQ1W0 | K103736 | 000 |
| B1605020B1 | K103736 | 000 |
| B1605003Y1 | K103736 | 000 |
| B1605006B1 | K103736 | 000 |
| 40193489957571 | K103736 | 000 |