FDA 510(k) Application Details - K240881

Device Classification Name Stapler, Surgical

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510(K) Number K240881
Device Name Stapler, Surgical
Applicant Covidien (Part of Medtronic)
60 Middletown Ave.
North Haven, CT 06473 US
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Contact Carolina Cabezas
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Regulation Number 878.4800

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Classification Product Code GAG
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Date Received 04/01/2024
Decision Date 11/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240881


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