The following data is part of a premarket notification filed by Noxilizer,inc. with the FDA for Noxilizer Surgical Ruler.
Device ID | K160501 |
510k Number | K160501 |
Device Name: | Noxilizer Surgical Ruler |
Classification | Tape, Measuring, Rulers And Calipers |
Applicant | Noxilizer,Inc. 800 West Baltimore Street Suite 151 Baltimore, MD 21201 |
Contact | Mary Dadone |
Correspondent | Mary Dadone Noxilizer,Inc. 800 West Baltimore Street Suite 151 Baltimore, MD 21201 |
Product Code | FTY |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-23 |
Decision Date | 2016-05-26 |
Summary: | summary |