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PK AIM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163373
510(k) Type
Special
Applicant
Gyrus ACMI Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/2016
Days to Decision
11 days
Submission Type
Summary

PK AIM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163373
510(k) Type
Special
Applicant
Gyrus ACMI Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/2016
Days to Decision
11 days
Submission Type
Summary