Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K091768 |
Device Name |
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES |
Applicant |
VISION-SCIENCES, INC. |
40 RAMLAND RD. SOUTH |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
LILLIAN QUINTERO |
Correspondent |
VISION-SCIENCES, INC. |
40 RAMLAND RD. SOUTH |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
LILLIAN QUINTERO |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 06/16/2009 |
Decision Date | 08/03/2009 |
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
|
|
|