510(k) K102741
K102741 is an FDA 510(k) premarket notification submitted by Shandong Weigao Group Medical Polymer Co., Ltd. for the device "ENTERAL FEEDING BAG AND SETS". The FDA issued a decision of Substantially Equivalent on Nov 8, 2011. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Shandong Weigao Group Medical Polymer Co., Ltd. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2011
- Date Received
- Sep 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)