FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ENTERAL FEEDING BAG AND SETS
K Number: K102741
·
Decision Nov 8, 2011
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
7
Review Days
412
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Basic Information
- Device Name
- ENTERAL FEEDING BAG AND SETS
- K Number
- K102741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shandong Weigao Group Medical Polymer Co., Ltd.
- Date Received
- September 22, 2010
- Decision Date
- November 8, 2011
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Shandong Weigao Group Medical Polymer Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212207 | Sterile Hypodermic Syringe for Single Use | Mar 23, 2023 | Substantially Equivalent |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use | Mar 11, 2022 | Substantially Equivalent |
| K102328 | BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA | May 13, 2011 | Substantially Equivalent |
| K081241 | WEIGAO EMPTY CARTRIDGE SYRINGE | Sep 8, 2008 | Substantially Equivalent |
| K072739 | JIERUI SYRINGES AND NEEDLES | Mar 21, 2008 | Substantially Equivalent |
| K073127 | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G | Dec 20, 2007 | Substantially Equivalent |