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FDA 510(k) Application Details - K993583
Device Classification Name
Replacement, Ossicular Prosthesis, Total
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510(K) Number
K993583
Device Name
Replacement, Ossicular Prosthesis, Total
Applicant
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001-6197 US
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NICOLE PETTY
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Regulation Number
874.3495
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Classification Product Code
ETA
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More FDA Info for this Product Code
Date Received
10/22/1999
Decision Date
11/10/1999
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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