FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL CONTAINMENT DEVICE
K Number: K913515
·
Decision May 26, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
1
Review Days
1023
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Basic Information
- Device Name
- TOTAL CONTAINMENT DEVICE
- K Number
- K913515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Denco
- Date Received
- August 7, 1991
- Decision Date
- May 26, 1994
- Product Code
- KPF
- 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 |
|---|---|---|---|
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | FDA class 2 | Gastroenterology, Urology |
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