The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Click Lock Multi-vas Infection Control Manifold.
| Device ID | K853275 |
| 510k Number | K853275 |
| Device Name: | CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD |
| Classification | Stopcock, I.v. Set |
| Applicant | ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649 |
| Contact | Dwight G Davis |
| Correspondent | Dwight G Davis ICU MEDICAL, INC. 5200 WARNER AVENUE, STE. 108 Huntington Beach, CA 92649 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-08-16 |