Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K011267 |
Device Name |
EXHALE RF PROBE |
Applicant |
BRONCUS TECHNOLOGIES, INC. |
1400N SHORELINE BLVD. |
BLDG. A, SUITE 8 |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
TIM R WILLIAMS |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 04/26/2001 |
Decision Date | 05/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|