FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A.V. FISTULA NEEDLE SET (#364)
K Number: K771491
·
Decision Aug 16, 1977
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
77
Applicant Total
69
Review Days
11
Basic Information
- Device Name
- A.V. FISTULA NEEDLE SET (#364)
- K Number
- K771491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- SORENSEN RESEARCH
- Date Received
- August 5, 1977
- Decision Date
- August 16, 1977
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
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JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
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