The following data is part of a premarket notification filed by Med-conduit, Inc. with the FDA for Hemocath Ii.
| Device ID | K062901 |
| 510k Number | K062901 |
| Device Name: | HEMOCATH II |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MED-CONDUIT, INC. 18 DERBY LANE Tyngsboro, MA 01879 |
| Contact | Gerald G Bousquet |
| Correspondent | Gerald G Bousquet 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 | 2006-09-27 |
| Decision Date | 2007-02-08 |
| Summary: | summary |