FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMALE URINE SAMPLING DEVICE
K Number: K922346
·
Decision Aug 14, 1992
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
9
Applicant Total
61
Review Days
87
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Basic Information
- Device Name
- FEMALE URINE SAMPLING DEVICE
- K Number
- K922346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- May 19, 1992
- Decision Date
- August 14, 1992
- Product Code
- FCN
- 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 |
|---|---|---|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
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