Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K981751 |
Device Name |
SINUSCOPE AND ACCESSORIES |
Applicant |
HENKE SASS WOLF OF AMERICA, INC. |
529 ASHLAND AVE. |
SOUTHBRIDGE,
MA
01550
|
|
Applicant Contact |
ELLEN J HENKE |
Correspondent |
HENKE SASS WOLF OF AMERICA, INC. |
529 ASHLAND AVE. |
SOUTHBRIDGE,
MA
01550
|
|
Correspondent Contact |
ELLEN J HENKE |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 05/18/1998 |
Decision Date | 08/13/1998 |
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
|
|
|