The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Pro-lock Ct Safety Infusion Set.
| Device ID | K162271 |
| 510k Number | K162271 |
| Device Name: | Pro-Lock CT Safety Infusion Set |
| Classification | Non-coring (huber) Needle |
| Applicant | MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-12 |
| Decision Date | 2017-04-26 |
| Summary: | summary |