Device Classification Name |
tissue expander and accessories
|
510(k) Number |
K102806 |
Device Name |
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS |
Applicant |
ALLERGAN MEDICAL |
71 S. LOS CARNEROS ROAD |
GOLETA,
CA
93117
|
|
Applicant Contact |
MICAH SCHLOSS |
Correspondent |
ALLERGAN MEDICAL |
71 S. LOS CARNEROS ROAD |
GOLETA,
CA
93117
|
|
Correspondent Contact |
MICAH SCHLOSS |
Classification Product Code |
|
Date Received | 09/28/2010 |
Decision Date | 01/05/2011 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|