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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K243128
Device Name Klockner Kits
Applicant
SOADCO, S.L.
Av. Del Pessebre, 76-82, Baixos
Escaldes-Engordany,  AD 25005
Applicant Contact Mercedes Roldan
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Rebecca Kattan
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/30/2024
Decision Date 12/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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