FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
VR MEDICAL ENTERAL ORAL SYRINGE
K Number: K110853
·
Decision May 13, 2011
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
2
Review Days
46
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Basic Information
- Device Name
- VR MEDICAL ENTERAL ORAL SYRINGE
- K Number
- K110853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vr Medical
- Date Received
- March 28, 2011
- Decision Date
- May 13, 2011
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Vr Medical
| K Number | Device Name | ||
|---|---|---|---|
| K132709 | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | Jul 30, 2014 | Substantially Equivalent |