The following data is part of a premarket notification filed by Medcomp with the FDA for Pro-picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing Tray.
| Device ID | K072509 |
| 510k Number | K072509 |
| Device Name: | PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-06 |
| Decision Date | 2007-11-26 |
| Summary: | summary |