The following data is part of a premarket notification filed by Medline Industries, Inc with the FDA for Konig Mogen Clamp.
Device ID | K212911 |
510k Number | K212911 |
Device Name: | Konig Mogen Clamp |
Classification | Clamp, Circumcision |
Applicant | Medline Industries, Inc Three Lakes Drive Northfield, IL 60093 |
Contact | Jennifer Mason |
Correspondent | Jennifer Mason Medline Industries, Inc Three Lakes Drive Northfield, IL 60093 |
Product Code | HFX |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-13 |
Decision Date | 2022-11-18 |