Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K984157 |
Device Name |
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
PAULA JOYCE |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
PAULA JOYCE |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 11/19/1998 |
Decision Date | 12/08/1998 |
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
|
|
|