MICRO-COIL 100 COIL DIALYZER— 510(k) K800723
Substantially EquivalentErika, Inc.
FDA 510(k) clearance K800723 for MICRO-COIL 100 COIL DIALYZER, Substantially Equivalent on 1980-05-14. Applicant: Erika, Inc.. Device class: 2.
Clearance details
- Applicant
- Erika, Inc.
- Product code
- Code FHS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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