Device Classification Name |
biopsy needle
|
510(k) Number |
K012358 |
Device Name |
CHIBA NEEDLE |
Applicant |
ISPG, INC. |
517 LITCHFIELD RD. |
NEW MILFORD,
CT
06776
|
|
Applicant Contact |
LORETTA F LUHMAN |
Correspondent |
ISPG, INC. |
517 LITCHFIELD RD. |
NEW MILFORD,
CT
06776
|
|
Correspondent Contact |
LORETTA F LUHMAN |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 07/25/2001 |
Decision Date | 10/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|