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SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150525
510(k) Type
Traditional
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2015
Days to Decision
263 days
Submission Type
Summary

SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150525
510(k) Type
Traditional
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2015
Days to Decision
263 days
Submission Type
Summary