Atlas FDA

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)

FDA 510(k) clearance K050827 · decided 2005-08-22

Clearance details

K-number
K050827
Device name
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
Applicant
Dialysis Solutions, Inc.
Decision
Substantially Equivalent
Date received
2005-04-01
Decision date
2005-08-22
Days to decision
143 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Lincolnshire, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.