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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K240460
Device Name FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
Applicant
Fmd Co., Ltd.
1-57-7
Sasazuka
Shibuya-Ku,  JP 151-0073
Applicant Contact Higashikubo Takashi
Correspondent
Fmd Co., Ltd.
2777 Yulupa Ave. Suite 303
Santa Rosa,  CA  95405 -8584
Correspondent Contact Bynum Maximilian
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/16/2024
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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