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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K251134
Device Name RipCord
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Valencia,  CA  91355
Applicant Contact Divya Raghavi Nandakumar
Correspondent
TriMed, Inc.
27533 Ave. Hopkins
Valencia,  CA  91355
Correspondent Contact Divya Raghavi Nandakumar
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Code
HWC  
Date Received04/11/2025
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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