FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K Number: K091340
·
Decision Jun 9, 2009
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
432
Review Days
34
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Basic Information
- Device Name
- THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
- K Number
- K091340
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- May 6, 2009
- Decision Date
- June 9, 2009
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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