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FDA 510(k) Application Details - K240127
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
510(K) Number
K240127
Device Name
Apparatus, Exhaust, Surgical
Applicant
CONMED Corporation
6455 South Yosemite Street
Greenwood Village, CO 80111 US
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Contact
Erin Hoffman
Other 510(k) Applications for this Contact
Regulation Number
878.5070
More FDA Info for this Regulation Number
Classification Product Code
FYD
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More FDA Info for this Product Code
Date Received
01/17/2024
Decision Date
08/05/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240127
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