The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Disposable Manifold System.
| Device ID | K863661 |
| 510k Number | K863661 |
| Device Name: | MEDCOMP DISPOSABLE MANIFOLD SYSTEM |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Rachel D Richardson |
| Correspondent | Rachel D Richardson MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-09-29 |