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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 K231291
Device Name Perforated Baskets
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Applicant Contact Mike McAndrew
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills,  IL  60061
Correspondent Contact Mike McAndrew
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/04/2023
Decision Date 06/03/2024
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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