FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FALLER STYLET
K Number: K130441
·
Decision Apr 19, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
47
Applicant Total
4
Review Days
57
Basic Information
- Device Name
- FALLER STYLET
- K Number
- K130441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDIONICS INTERNATIONAL, INC.
- Date Received
- February 21, 2013
- Decision Date
- April 19, 2013
- Product Code
- FJS
- 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
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