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EVITA 2 DURA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970165
510(k) Type
Traditional
Applicant
DRAGER, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
8/26/1997
Days to Decision
222 days

EVITA 2 DURA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970165
510(k) Type
Traditional
Applicant
DRAGER, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
8/26/1997
Days to Decision
222 days