The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Retractable Safety Syringe.
Device ID | K101560 |
510k Number | K101560 |
Device Name: | MEDLINE RETRACTABLE SAFETY SYRINGE |
Classification | Syringe, Antistick |
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 | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-04 |
Decision Date | 2011-03-25 |
Summary: | summary |