The following data is part of a premarket notification filed by Micor, Inc. with the FDA for Spring-wound Epidural Catheter.
Device ID | K991879 |
510k Number | K991879 |
Device Name: | SPRING-WOUND EPIDURAL CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | MICOR, INC. 2855 OXFORD BLVD. Allison Park, PA 15101 |
Contact | Charles W Esleep |
Correspondent | Charles W Esleep 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 | 1999-06-02 |
Decision Date | 1999-10-28 |
Summary: | summary |