The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medicomp Flexi-smooth Wound Drainage Catheter.
| Device ID | K960426 |
| 510k Number | K960426 |
| Device Name: | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER |
| Classification | Catheter, Peritoneal |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Michelle Demers |
| Correspondent | Michelle Demers MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-03-21 |