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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
K152219
510(k) Type
Traditional
Applicant
GYRUS ACMI INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2015
Days to Decision
132 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
K152219
510(k) Type
Traditional
Applicant
GYRUS ACMI INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2015
Days to Decision
132 days
Submission Type
Summary