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SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172618
510(k) Type
Traditional
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
12/5/2017
Days to Decision
96 days
Submission Type
Summary