FDA 510(k) Application Details - K230281

Device Classification Name Clamp, Vascular

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510(K) Number K230281
Device Name Clamp, Vascular
Applicant Kono Seisakusho Co., Ltd
2-11-10
Soya
Ichikawa city 272-0837 JP
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Contact Aya Takagi
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 02/01/2023
Decision Date 10/23/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K230281


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