The following data is part of a premarket notification filed by Med-conduit, Inc. with the FDA for Hemocath.
Device ID | K043292 |
510k Number | K043292 |
Device Name: | HEMOCATH |
Classification | Catheter, Hemodialysis, Implanted |
Applicant | MED-CONDUIT, INC. 18 DERBY LANE Tyngsboro, MA 01879 |
Contact | Robert W Cunningham |
Correspondent | Robert W Cunningham MED-CONDUIT, INC. 18 DERBY LANE Tyngsboro, MA 01879 |
Product Code | MSD |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-29 |
Decision Date | 2005-03-16 |
Summary: | summary |