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NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123395
510(k) Type
Traditional
Applicant
NXSTAGE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/7/2013
Days to Decision
122 days
Submission Type
Summary

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123395
510(k) Type
Traditional
Applicant
NXSTAGE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/7/2013
Days to Decision
122 days
Submission Type
Summary