BICARB-O-MATE HEMODIALYSIS SOD. BICARB.— 510(k) K802465

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K802465 for BICARB-O-MATE HEMODIALYSIS SOD. BICARB., Substantially Equivalent on 1980-11-12. Applicant: Renal Systems, Inc..

Clearance details

Applicant
Renal Systems, Inc.
Product code
Code FKR
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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