AMICON EQUALINE FLUID BALANCE SYSTEM— 510(k) K875121
Substantially EquivalentAmicon, Inc.
FDA 510(k) clearance K875121 for AMICON EQUALINE FLUID BALANCE SYSTEM, Substantially Equivalent on 1988-02-19. Applicant: Amicon, Inc.. Device class: 2.
Clearance details
- Applicant
- Amicon, Inc.
- Product code
- Code KPF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
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