Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K854581 |
Device Name |
MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 |
Applicant |
MACHIDA AMERICA, INC. |
40 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
JAMES BRADLEY |
Correspondent |
MACHIDA AMERICA, INC. |
40 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
JAMES BRADLEY |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 11/15/1985 |
Decision Date | 02/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|