FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
K Number: K950784
·
Decision May 3, 1995
Classifications
1
FEI Numbers
417
Registration Numbers
418
Same Product Code
55
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
- K Number
- K950784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5920
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Bioresearch Assoc.
- Date Received
- February 21, 1995
- Decision Date
- May 3, 1995
- Product Code
- EYQ
- 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | FDA class 1 | Gastroenterology, Urology |
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