FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTECARE PEDIATRIC URINE COLLECTOR
K Number: K871789
·
Decision Aug 10, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
2
Applicant Total
3
Review Days
96
Basic Information
- Device Name
- INTECARE PEDIATRIC URINE COLLECTOR
- K Number
- K871789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- MERCURY ENTERPRISES, INC.
- Date Received
- May 6, 1987
- Decision Date
- August 10, 1987
- Product Code
- FFH
- 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 |
|---|---|---|---|
| FFH | Collector, Urine, Pediatric, For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
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