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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 K203572
Device Name Karl Storz Radel Sterilization Trays
Applicant
Karl Storz Endoscopy America, Inc.
2151 E Grand Ave.
El Segundo,  CA  90245 -5017
Applicant Contact Leigh Spotten
Correspondent
Toscano Consulting Group, Inc.
8708 Capeheart Cove
Austin,  TX  78733
Correspondent Contact David Furr
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/07/2020
Decision Date 05/07/2021
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
Recalls CDRH Recalls
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