Device Classification Name |
Tape, Measuring, Rulers And Calipers
|
510(k) Number |
K160501 |
FOIA Releasable 510(k) |
K160501
|
Device Name |
Noxilizer Surgical Ruler |
Applicant |
Noxilizer,Inc. |
800 West Baltimore Street |
Suite 151 |
Baltimore,
MD
21201
|
|
Applicant Contact |
Mary Dadone |
Correspondent |
Noxilizer,Inc. |
800 West Baltimore Street |
Suite 151 |
Baltimore,
MD
21201
|
|
Correspondent Contact |
Mary Dadone |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/2016 |
Decision Date | 05/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|