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Blue Sky Bio Zygomatic Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190491
510(k) Type
Traditional
Applicant
Blue Sky Bio, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2019
Days to Decision
165 days
Submission Type
Summary

Blue Sky Bio Zygomatic Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190491
510(k) Type
Traditional
Applicant
Blue Sky Bio, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2019
Days to Decision
165 days
Submission Type
Summary