FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE ANTI-REFLUX VALVE
K Number: K132314
·
Decision Sep 18, 2013
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
12
Applicant Total
238
Review Days
55
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Basic Information
- Device Name
- MEDLINE ANTI-REFLUX VALVE
- K Number
- K132314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- July 25, 2013
- Decision Date
- September 18, 2013
- Product Code
- FEG
- 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 |
|---|---|---|---|
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FDA class 2 | Gastroenterology, Urology |
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