FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRO-CLENZ UNIT
K Number: K863539
·
Decision Oct 16, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
39
Applicant Total
1
Review Days
35
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Basic Information
- Device Name
- HYDRO-CLENZ UNIT
- K Number
- K863539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5220
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Atlantic Health Group
- Date Received
- September 11, 1986
- Decision Date
- October 16, 1986
- Product Code
- KPL
- 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 |
|---|---|---|---|
| KPL | Colonic Irrigation System | FDA class 2 | Gastroenterology, Urology |
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