PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)— 510(k) K970648
Substantially EquivalentRenal Systems, Inc.
FDA 510(k) clearance K970648 for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S), Substantially Equivalent on 1998-01-05. Applicant: Renal Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Renal Systems, Inc.
- Product code
- Code MSF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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