The following data is part of a premarket notification filed by Medcomp with the FDA for Split Cath Rg.
Device ID | K130889 |
510k Number | K130889 |
Device Name: | SPLIT CATH RG |
Classification | Catheter, Hemodialysis, Implanted |
Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
Contact | Timothy Holwick |
Correspondent | Timothy Holwick MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
Product Code | MSD |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-29 |
Decision Date | 2014-04-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPLIT CATH RG 85820368 4731973 Live/Registered |
Medical Components, Inc. 2013-01-10 |