The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Epidural Catheter.
Device ID | K150731 |
510k Number | K150731 |
Device Name: | Medline Epidural Catheter |
Classification | Catheter, Conduction, Anesthetic |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Contact | Matt Clausen |
Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-20 |
Decision Date | 2016-03-07 |
Summary: | summary |