The following data is part of a premarket notification filed by Medcomp with the FDA for 14f X 24cm Ash Split-cath,14f X 28cm Ash Split-cath, 14f X 32cm Ash Split-cath, 14fx36cm Ash Split-cath, 14f X 40cm Ash.
| Device ID | K013162 |
| 510k Number | K013162 |
| Device Name: | 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jeanne M Cush |
| Correspondent | Jeanne M Cush MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-21 |
| Decision Date | 2001-10-19 |
| Summary: | summary |