The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Peritoneal Lavage Cath Plc-8,set Pls-8, Kit Plk-8.
| Device ID | K860155 |
| 510k Number | K860155 |
| Device Name: | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Micheal I Basta |
| Correspondent | Micheal I Basta MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-16 |
| Decision Date | 1986-02-14 |