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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 K220650
Device Name TriMed Ripcord Device
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita,  CA  91355
Applicant Contact David Medoff
Tech2Med, LLC
6450 Old Darby TRL NE
Ada,  MI  49301
Correspondent Contact David Anderson
Regulation Number888.3030
Classification Product Code
Date Received03/07/2022
Decision Date 06/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls