Device Classification Name |
Staple, Implantable
|
510(k) Number |
K030653 |
Device Name |
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS |
Applicant |
POWER MEDICAL INTERVENTIONS, INC. |
110 UNION SQUARE DR. |
NEW HOPE,
PA
18938 -1364
|
|
Applicant Contact |
BABARA J WHITMAN |
Correspondent |
POWER MEDICAL INTERVENTIONS, INC. |
110 UNION SQUARE DR. |
NEW HOPE,
PA
18938 -1364
|
|
Correspondent Contact |
BABARA J WHITMAN |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 03/03/2003 |
Decision Date | 03/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|