The following data is part of a premarket notification filed by Covidien Llc with the FDA for Accumesh Deployment System.
Device ID | K123066 |
510k Number | K123066 |
Device Name: | ACCUMESH DEPLOYMENT SYSTEM |
Classification | Mesh, Surgical, Deployer |
Applicant | Covidien LLC 15 CROSBY DRIVE Bedford, MA 01730 |
Contact | Elizabeth Mcmeniman |
Correspondent | Elizabeth Mcmeniman Covidien LLC 15 CROSBY DRIVE Bedford, MA 01730 |
Product Code | ORQ |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-01 |
Decision Date | 2012-10-16 |
Summary: | summary |