The following data is part of a premarket notification filed by Feg Textiltechnik Forschungs-und Entwicklungsgesel with the FDA for Dynamesh-pp Standard, Model Pp02nnnn, Dynamesh-pp Light, Model Pp01nnnn.
Device ID | K073579 |
510k Number | K073579 |
Device Name: | DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN |
Classification | Mesh, Surgical, Polymeric |
Applicant | FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL BUSINESS & TECHNOLOGY CENTER/ BESSEMER DRIVE Stevenage, GB Sg1 2dx |
Contact | Neil R Armstrong |
Correspondent | Neil R Armstrong FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL BUSINESS & TECHNOLOGY CENTER/ BESSEMER DRIVE Stevenage, GB Sg1 2dx |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-20 |
Decision Date | 2008-08-18 |
Summary: | summary |