HYDRO-CLENZ UNIT
FDA 510(k) clearance K863539 · decided 1986-10-16
Clearance details
- K-number
- K863539
- Device name
- HYDRO-CLENZ UNIT
- Applicant
- Atlantic Health Group
- Decision
- Substantially Equivalent
- Date received
- 1986-09-11
- Decision date
- 1986-10-16
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.