FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
K Number: K071145
·
Decision Sep 7, 2007
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
37
Applicant Total
34
Review Days
136
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Basic Information
- Device Name
- NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
- K Number
- K071145
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- April 24, 2007
- Decision Date
- September 7, 2007
- Product Code
- MPB
- 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 |
|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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