FDA 510(k) Application Details - K240127

Device Classification Name Apparatus, Exhaust, Surgical

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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
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Regulation Number 878.5070

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Classification Product Code FYD
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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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