The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Freedom Syringe.
Device ID | K161812 |
510k Number | K161812 |
Device Name: | Freedom Syringe |
Classification | Syringe, Piston |
Applicant | Procedure Products, Inc. 1801 W. 4th Plain Blvd. Vancouver, WA 98660 |
Contact | Doug Rowley |
Correspondent | Doug Rowley Procedure Products, Inc. 1801 W. 4th Plain Blvd. Vancouver, WA 98660 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-01 |
Decision Date | 2017-03-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B1601020W1 | K161812 | 000 |
B1601010B1 | K161812 | 000 |
B1601003G1 | K161812 | 000 |
B1601001R1 | K161812 | 000 |
B1601006B1 | K161812 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FREEDOM SYRINGE 86508107 5057116 Live/Registered |
Bynum, W. Richard 2015-01-20 |