The following data is part of a premarket notification filed by Medcomp (medical Components) with the FDA for Pro-line Ct (basic Tray) Model Mr28036101.
| Device ID | K093309 |
| 510k Number | K093309 |
| Device Name: | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP (MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-22 |
| Decision Date | 2009-11-24 |
| Summary: | summary |