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ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131053
510(k) Type
Traditional
Applicant
THE ANSPACH EFFORT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/31/2013
Days to Decision
259 days
Submission Type
Summary

ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131053
510(k) Type
Traditional
Applicant
THE ANSPACH EFFORT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/31/2013
Days to Decision
259 days
Submission Type
Summary