Device Classification Name |
otoscope
|
510(k) Number |
K110326 |
Device Name |
OSRAM ITOS |
Applicant |
OSRAM SYLVANIA, INC. |
1801 ROCKVILLE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
MARIE A SCHROEDER |
Correspondent |
OSRAM SYLVANIA, INC. |
1801 ROCKVILLE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
MARIE A SCHROEDER |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 02/03/2011 |
Decision Date | 10/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|