The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Enteral Feeding Sets.
Device ID | K150286 |
510k Number | K150286 |
Device Name: | Medline Enteral Feeding Sets |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
Contact | Stephanie Blair |
Correspondent | Stephanie Blair MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-05 |
Decision Date | 2015-04-27 |
Summary: | summary |