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HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102936
510(k) Type
Traditional
Applicant
BAXTER HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2011
Days to Decision
177 days
Submission Type
Summary

HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102936
510(k) Type
Traditional
Applicant
BAXTER HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/2011
Days to Decision
177 days
Submission Type
Summary