The following data is part of a premarket notification filed by Micor, Inc. with the FDA for Conduction Catheter.
Device ID | K031600 |
510k Number | K031600 |
Device Name: | CONDUCTION CATHETER |
Classification | Pump, Infusion |
Applicant | MICOR, INC. 2855 OXFORD BLVD. Allison Park, PA 15101 |
Contact | Susan Forgrave |
Correspondent | Susan Forgrave MICOR, INC. 2855 OXFORD BLVD. Allison Park, PA 15101 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-21 |
Decision Date | 2003-08-13 |
Summary: | summary |