The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Popmesh.
Device ID | K053424 |
510k Number | K053424 |
Device Name: | POPMESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 |
Contact | Marla Kengen |
Correspondent | Marla Kengen CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-08 |
Decision Date | 2006-02-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POPMESH 78482818 3115183 Dead/Cancelled |
Caldera Medical, Inc. 2004-09-13 |