The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Catheter Specimen Collector.
Device ID | K172541 |
510k Number | K172541 |
Device Name: | Medline Catheter Specimen Collector |
Classification | Catheter, Straight |
Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Contact | Dinah Rincones |
Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Product Code | EZD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-23 |
Decision Date | 2018-02-22 |
Summary: | summary |