| Device Classification Name |
Instrument, Biopsy
|
| 510(k) Number |
K874314 |
| Device Name |
WILSON-COOK BIOPSY FORCEPS |
| Applicant |
| Wilson-Cook Medical, Inc. |
| 4900 Bethania Station Rd. & |
| 5951 Grassy Creek Blvd. |
|
Winston-Salem,
NC
27105
|
|
| Applicant Contact |
ROBERT M KELLY |
| Correspondent |
| Wilson-Cook Medical, Inc. |
| 4900 Bethania Station Rd. & |
| 5951 Grassy Creek Blvd. |
|
Winston-Salem,
NC
27105
|
|
| Correspondent Contact |
ROBERT M KELLY |
| Regulation Number | 876.1075 |
| Classification Product Code |
|
| Date Received | 10/20/1987 |
| Decision Date | 12/07/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|