Device Classification Name |
Applier, Aneurysm Clip
|
510(k) Number |
K994191 |
Device Name |
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T |
Applicant |
NMT MEDICAL, INC. |
1733 CANTON LN. |
MARIETTA,
GA
30062
|
|
Applicant Contact |
RONALD D ARKIN |
Correspondent |
NMT MEDICAL, INC. |
1733 CANTON LN. |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
RONALD D ARKIN |
Regulation Number | 882.4175
|
Classification Product Code |
|
Date Received | 12/13/1999 |
Decision Date | 02/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|