The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Latex Foley Catheter.
Device ID | K071423 |
510k Number | K071423 |
Device Name: | MEDLINE LATEX FOLEY CATHETER |
Classification | Catheter, Retention Type, Balloon |
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 | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-22 |
Decision Date | 2007-07-18 |
Summary: | summary |