Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K071470 |
Device Name |
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX |
Applicant |
IMPLANTECH ASSOCIATES INC. |
6025 NICOLLE ST., SUITE B |
VENTURA,
CA
93003
|
|
Applicant Contact |
STEPHEN MEADE |
Correspondent |
IMPLANTECH ASSOCIATES INC. |
6025 NICOLLE ST., SUITE B |
VENTURA,
CA
93003
|
|
Correspondent Contact |
STEPHEN MEADE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/29/2007 |
Decision Date | 08/31/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|