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FDA 510(k) Application Details - K050340
Device Classification Name
Cannula, Sinus
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510(K) Number
K050340
Device Name
Cannula, Sinus
Applicant
MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
SUITE 120
EAGAN, MN 55121 US
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Contact
THOMAS A LOPAC
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
KAM
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More FDA Info for this Product Code
Date Received
02/11/2005
Decision Date
04/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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