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FDA 510(k) Application Details - K060750
Device Classification Name
Cement, Ear, Nose And Throat
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510(K) Number
K060750
Device Name
Cement, Ear, Nose And Throat
Applicant
STRYKER CMF
750 TRADE CENTRE WAY
KALAMAZOO, MI 49001 US
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Contact
WADE T RUTKOSKIE
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Regulation Number
872.3275
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Classification Product Code
NEA
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More FDA Info for this Product Code
Date Received
03/21/2006
Decision Date
04/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
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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