GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET— 510(k) K955497
Substantially EquivalentCobe Renal Care, Inc.
FDA 510(k) clearance K955497 for GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET, Substantially Equivalent on 1997-09-25. Applicant: Cobe Renal Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Renal Care, Inc.
- Product code
- Code KDL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5880
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code KDL
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