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FDA 510(k) Application Details - K082074
Device Classification Name
Unit, Cryosurgical, Accessories
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510(K) Number
K082074
Device Name
Unit, Cryosurgical, Accessories
Applicant
ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER, OH 45069 US
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Contact
JAMES LUCKY
Other 510(k) Applications for this Contact
Regulation Number
878.4350
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Classification Product Code
GEH
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More FDA Info for this Product Code
Date Received
07/23/2008
Decision Date
03/02/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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