The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Vaclok Syringe.
| Device ID | K994253 |
| 510k Number | K994253 |
| Device Name: | VACLOK SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816777026706 | K994253 | 000 |
| 00643169582224 | K994253 | 000 |