Device Classification Name |
Punch, Biopsy
|
510(k) Number |
K895885 |
Device Name |
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING |
Applicant |
NATIONAL-STANDARD CO. |
4445-360 S.W. 35TH TERRACE |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
ROBINSON |
Correspondent |
NATIONAL-STANDARD CO. |
4445-360 S.W. 35TH TERRACE |
GAINESVILLE,
FL
32608
|
|
Correspondent Contact |
ROBINSON |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 10/05/1989 |
Decision Date | 02/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|