Device Classification Name |
holder, needle, gastroenterologic
|
510(k) Number |
K930330 |
Device Name |
ENDOSCOPIC NEEDLEHOLDER, MODIFICATION |
Applicant |
HOLMED CORP. |
40 NORFOLK AVE. |
SOUTH EASTON,
MA
02375
|
|
Applicant Contact |
RUSSELL P HOLMES |
Correspondent |
HOLMED CORP. |
40 NORFOLK AVE. |
SOUTH EASTON,
MA
02375
|
|
Correspondent Contact |
RUSSELL P HOLMES |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 01/22/1993 |
Decision Date | 06/08/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|