Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K070580 |
Device Name |
NASOPHARYNGOSCOPE, BRONCHOSCOPE |
Applicant |
XION GMBH |
PANKSTR. 8-10 |
BERLIN,
DE
13127
|
|
Applicant Contact |
ALEXANDER KLIEM |
Correspondent |
XION GMBH |
PANKSTR. 8-10 |
BERLIN,
DE
13127
|
|
Correspondent Contact |
ALEXANDER KLIEM |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 03/01/2007 |
Decision Date | 06/13/2007 |
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
|
|
|