The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Modified 10cc Syringe Control Ring Set.
| Device ID | K884985 |
| 510k Number | K884985 |
| Device Name: | MODIFIED 10CC SYRINGE CONTROL RING SET |
| Classification | Syringe, Piston |
| Applicant | PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Contact | Bob Everett |
| Correspondent | Bob Everett PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD. Vancouver, WA 98660 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-01 |
| Decision Date | 1988-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1605370R2 | K884985 | 000 |
| B1604410Y322 | K884985 | 000 |
| B1604920Y1 | K884985 | 000 |
| B1604930G21 | K884985 | 000 |
| B1604930V1 | K884985 | 000 |
| B1604930W2 | K884985 | 000 |
| B1604940R1 | K884985 | 000 |
| B1604960R1 | K884985 | 000 |
| B1605318G1 | K884985 | 000 |
| B1604410R1 | K884985 | 000 |