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SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033554
510(k) Type
Traditional
Applicant
GYRUS ENT L.L.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/24/2003
Days to Decision
12 days
Submission Type
Summary

SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033554
510(k) Type
Traditional
Applicant
GYRUS ENT L.L.C.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/24/2003
Days to Decision
12 days
Submission Type
Summary