Device Classification Name |
cement, ear, nose and throat
|
510(k) Number |
K140644 |
Device Name |
PROCEM |
Applicant |
OTOTRONIX, LLC |
4486 TIMBERLINE CT |
ST PAUL,
MN
55127
|
|
Applicant Contact |
BERNARD HORWATH |
Correspondent |
OTOTRONIX, LLC |
4486 TIMBERLINE CT |
ST PAUL,
MN
55127
|
|
Correspondent Contact |
BERNARD HORWATH |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 03/13/2014 |
Decision Date | 06/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|