The following data is part of a premarket notification filed by Monumedical, Llc with the FDA for Turnsignal Stopcocks Sterile, Turnsignal Stopcocks Buld Non Sterile, Turnsignal Stopcocks With Manifolds Sterile, Turnsignal Stopcocks With Manifolds Bulk Non Sterile.
| Device ID | K190539 |
| 510k Number | K190539 |
| Device Name: | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks With Manifolds Sterile, TurnSignal Stopcocks With Manifolds Bulk Non Sterile |
| Classification | Stopcock, I.v. Set |
| Applicant | MonuMedical, LLC 3017 Douglas Blvd, Suite 300 Roseville, CA 95661 |
| Contact | John Knapik |
| Correspondent | Cheryl Blake Cheryl Blake 27392 Capricho Mission Viejo, CA 92692 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-10-22 |
| Summary: | summary |