SHUNT ADAPTER— 510(k) K813428
Substantially EquivalentQuinton, Inc.
FDA 510(k) clearance K813428 for SHUNT ADAPTER, Substantially Equivalent on 1981-12-31. Applicant: Quinton, Inc.. Device class: 2.
Clearance details
- Applicant
- Quinton, Inc.
- Product code
- Code FKN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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