Device Classification Name |
clip, implantable
|
510(k) Number |
K032238 |
Device Name |
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER |
Applicant |
NEUROSEL (MEDICAL) LIMITED |
GREENWAYS |
ABBOTTS ANN |
ANDOVER, HAMPSHIRE,
GB
SP11 7BH
|
|
Applicant Contact |
PETER GIBSON |
Correspondent |
NEUROSEL (MEDICAL) LIMITED |
GREENWAYS |
ABBOTTS ANN |
ANDOVER, HAMPSHIRE,
GB
SP11 7BH
|
|
Correspondent Contact |
PETER GIBSON |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/21/2003 |
Decision Date | 09/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|