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DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973510
510(k) Type
Traditional
Applicant
IMMUNO-U.S., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/8/1997
Days to Decision
83 days
Submission Type
Summary

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973510
510(k) Type
Traditional
Applicant
IMMUNO-U.S., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/8/1997
Days to Decision
83 days
Submission Type
Summary