FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVEEN(R) LEG BAG(500 ML)
K Number: K924406
·
Decision Oct 30, 1992
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
17
Applicant Total
71
Review Days
66
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Basic Information
- Device Name
- CONVEEN(R) LEG BAG(500 ML)
- K Number
- K924406
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coloplast A/S
- Date Received
- August 25, 1992
- Decision Date
- October 30, 1992
- Product Code
- FAQ
- 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 |
|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | FDA class 1 | Gastroenterology, Urology |
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