Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K091011 |
Device Name |
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) |
Applicant |
SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") |
610 CLEMSON ROAD |
COLUMBIA,
SC
29229
|
|
Applicant Contact |
MATHEW FAIRFAX |
Correspondent |
SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") |
610 CLEMSON ROAD |
COLUMBIA,
SC
29229
|
|
Correspondent Contact |
MATHEW FAIRFAX |
Regulation Number | 878.3550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2009 |
Decision Date | 04/22/2009 |
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
|
|
|