The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Patient Cables And Lead Wires.
Device ID | K181726 |
510k Number | K181726 |
Device Name: | Medline Patient Cables And Lead Wires |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
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 | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-29 |
Decision Date | 2018-09-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20888277697543 | K181726 | 000 |