The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Medcomp Power Injectable Safety Huber Needle.
| Device ID | K132880 |
| 510k Number | K132880 |
| Device Name: | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2014-01-08 |
| Summary: | summary |