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FLOSENSE, MODEL 29-8010

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990962
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/2000
Days to Decision
291 days
Submission Type
Statement

FLOSENSE, MODEL 29-8010

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990962
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/2000
Days to Decision
291 days
Submission Type
Statement