Device Classification Name |
biopsy needle
|
510(k) Number |
K915801 |
Device Name |
BIP-COAX-SYSTEM |
Applicant |
UNI-QUATRO INDUSTRIES CANADA, INC. |
6471 KISTER RD. |
NIAGARA FALLS, ONTARIO,
CA
L2E 6X8
|
|
Applicant Contact |
SIEGFRIED GRUCHOT |
Correspondent |
UNI-QUATRO INDUSTRIES CANADA, INC. |
6471 KISTER RD. |
NIAGARA FALLS, ONTARIO,
CA
L2E 6X8
|
|
Correspondent Contact |
SIEGFRIED GRUCHOT |
Regulation Number | 876.1075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 03/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|