The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co.,ltd. with the FDA for Enteral Feeding Bag And Sets.
Device ID | K102741 |
510k Number | K102741 |
Device Name: | ENTERAL FEEDING BAG AND SETS |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai, CN 200030 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-22 |
Decision Date | 2011-11-08 |
Summary: | summary |