The following data is part of a premarket notification filed by Med-conduit, Inc. with the FDA for Pd Cath.
Device ID | K053123 |
510k Number | K053123 |
Device Name: | PD CATH |
Classification | Catheter, Peritoneal, Long-term Indwelling |
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 | FJS |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-07 |
Decision Date | 2006-03-29 |
Summary: | summary |