GAMBRO AK-10-UDM-10-A ULTRADIFFUSION— 510(k) K800425
Substantially EquivalentGambro, Inc.
FDA 510(k) clearance K800425 for GAMBRO AK-10-UDM-10-A ULTRADIFFUSION, Substantially Equivalent on 1980-04-08. Applicant: Gambro, Inc.. Device class: 2.
Clearance details
- Applicant
- Gambro, Inc.
- Product code
- Code FKP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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