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 |