The following data is part of a premarket notification filed by Alure Medical Inc. with the FDA for Refine Support System, Model 100.0100.
Device ID | K092538 |
510k Number | K092538 |
Device Name: | REFINE SUPPORT SYSTEM, MODEL 100.0100 |
Classification | Mesh, Surgical, Polymeric |
Applicant | ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa, CA 95403 |
Contact | Joseph Tamayo |
Correspondent | Joseph Tamayo ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa, CA 95403 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-19 |
Decision Date | 2010-03-05 |
Summary: | summary |