The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Quad Lumen, 8.5f X 20cm, Model Mc4l-8s.
| Device ID | K010021 |
| 510k Number | K010021 |
| Device Name: | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Florence A Caikoski |
| Correspondent | Florence A Caikoski MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-02-23 |