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FDA 510(k) Application Details - K060518
Device Classification Name
Prosthesis, Partial Ossicular Replacement
More FDA Info for this Device
510(K) Number
K060518
Device Name
Prosthesis, Partial Ossicular Replacement
Applicant
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS, TN 38133 US
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Contact
JEFF COBB
Other 510(k) Applications for this Contact
Regulation Number
874.3450
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Classification Product Code
ETB
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More FDA Info for this Product Code
Date Received
02/27/2006
Decision Date
06/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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