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 |