The following data is part of a premarket notification filed by Allergan Medical with the FDA for Natrelle 133 Tissue Expander With Suture Tabs.
Device ID | K102806 |
510k Number | K102806 |
Device Name: | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS |
Classification | Expander, Skin, Inflatable |
Applicant | ALLERGAN MEDICAL 71 S. LOS CARNEROS ROAD Goleta, CA 93117 |
Contact | Micah Schloss |
Correspondent | Micah Schloss ALLERGAN MEDICAL 71 S. LOS CARNEROS ROAD Goleta, CA 93117 |
Product Code | LCJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-28 |
Decision Date | 2011-01-05 |
Summary: | summary |