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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K240438
Device Name CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
Applicant
Comercializadora Brever
Omega 102 Local
Leon,  MX
Applicant Contact Clarisbeth Flores Lara
Correspondent
Comercializadora Brever
Omega 102 Local
Leon,  MX
Correspondent Contact Clarisbeth Flores Lara
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/14/2024
Decision Date 11/04/2024
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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