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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K233322
Device Name Mochida Nerve Cuff
Applicant
Mochida Pharmaceutical Co., Ltd.
1-7 Yotsuya
Shinjyuku-Ku,  JP 160-8515
Applicant Contact Akiko Koarai
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Kelliann H. Payne
Regulation Number882.5275
Classification Product Code
JXI  
Date Received09/29/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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