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FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183683
510(k) Type
Special
Applicant
FUJIFILM Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
2/27/2019
Days to Decision
61 days
Submission Type
Summary

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183683
510(k) Type
Special
Applicant
FUJIFILM Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
2/27/2019
Days to Decision
61 days
Submission Type
Summary