Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K021344 |
FOIA Releasable 510(k) |
K021344
|
Device Name |
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM |
Applicant |
VISION-SCIENCES, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
VISION-SCIENCES, INC. |
5 WHITCOMB AVE. |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 04/29/2002 |
Decision Date | 05/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|