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Kepler II

Page Type
Cleared 510(K)
510(k) Number
K163265
510(k) Type
Traditional
Applicant
Orbbo Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/7/2017
Days to Decision
137 days
Submission Type
Summary

Kepler II

Page Type
Cleared 510(K)
510(k) Number
K163265
510(k) Type
Traditional
Applicant
Orbbo Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/7/2017
Days to Decision
137 days
Submission Type
Summary