The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Caldera Mesh.
Device ID | K060004 |
510k Number | K060004 |
Device Name: | CALDERA MESH |
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 | 2006-01-03 |
Decision Date | 2006-02-22 |
Summary: | summary |