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Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221845
510(k) Type
Abbreviated
Applicant
Blue Sky Bio, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/24/2023
Days to Decision
245 days
Submission Type
Summary

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221845
510(k) Type
Abbreviated
Applicant
Blue Sky Bio, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/24/2023
Days to Decision
245 days
Submission Type
Summary