Device Classification Name |
staple, implantable
|
510(k) Number |
K983318 |
Device Name |
FIXATION SYSTEM |
Applicant |
GENERAL SURGICAL INNOVATIONS |
10460 BUBB RD. |
CUPERTINO,
CA
95014
|
|
Applicant Contact |
FEROLYN T POWELL |
Correspondent |
GENERAL SURGICAL INNOVATIONS |
10460 BUBB RD. |
CUPERTINO,
CA
95014
|
|
Correspondent Contact |
FEROLYN T POWELL |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 09/21/1998 |
Decision Date | 03/01/1999 |
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
|
|
|