The following data is part of a premarket notification filed by Micor, Inc. with the FDA for Micor Conduction Catheter.
Device ID | K001717 |
510k Number | K001717 |
Device Name: | MICOR CONDUCTION CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | MICOR, INC. 2855 OXFORD BLVD. Allison Park, PA 15101 |
Contact | Jeremiah Costello |
Correspondent | Jeremiah Costello MICOR, INC. 2855 OXFORD BLVD. Allison Park, PA 15101 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-05 |
Decision Date | 2000-09-20 |