Device Classification Name |
Clip, Implantable
|
510(k) Number |
K030269 |
Device Name |
GENICON CLIP APPLIER |
Applicant |
GENICON, LC |
P.O. BOX 780038 |
ORLANDO,
FL
32878 -0038
|
|
Applicant Contact |
FRANK GOLDFARB |
Correspondent |
GENICON, LC |
P.O. BOX 780038 |
ORLANDO,
FL
32878 -0038
|
|
Correspondent Contact |
FRANK GOLDFARB |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/27/2003 |
Decision Date | 03/20/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|