The following data is part of a premarket notification filed by Vr Medical Technology Co., Ltd with the FDA for Vr Medical Feeding Tube And Enteral Feeding Extension Set (efes).
Device ID | K180236 |
510k Number | K180236 |
Device Name: | VR Medical Feeding Tube And Enteral Feeding Extension Set (EFES) |
Classification | Tube, Feeding |
Applicant | VR MEDICAL TECHNOLOGY CO., LTD No. 90 Gaoxin Rd. Zhouzhuang, CN 215325 |
Contact | Lee Pan |
Correspondent | Paul Dryden VR Medical C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
Product Code | FPD |
Subsequent Product Code | KNT |
Subsequent Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-29 |
Decision Date | 2019-01-18 |
Summary: | summary |