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BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011438
510(k) Type
Traditional
Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2001
Days to Decision
74 days
Submission Type
Summary

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011438
510(k) Type
Traditional
Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2001
Days to Decision
74 days
Submission Type
Summary