URO-TOUCH 9 French Probe— 510(k) K202813
Substantially EquivalentNorthgate Technologies, Inc.
FDA 510(k) clearance K202813 for URO-TOUCH 9 French Probe, Substantially Equivalent on 2021-06-14. Applicant: Northgate Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Northgate Technologies, Inc.
- Product code
- Code FFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elgin, IL, US
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