The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Control Syringe.
| Device ID | K884497 |
| 510k Number | K884497 |
| Device Name: | CONTROL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Contact | James E Williams |
| Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1988-12-12 |