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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Laryngeal (Taub)
510(k) Number K240763
Device Name FirstFit Surgical Kit
Applicant
Freudenberg Medical, LLC
1110 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact Oliver Krause-Huckelberry
Correspondent
O'Connell & Myers, LLC
1110 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact Trey Thorsen
Regulation Number874.3730
Classification Product Code
EWL  
Date Received03/20/2024
Decision Date 12/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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