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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 K201945
Device Name KARL STORZ UDEL Sterilization Trays
Applicant
Karl Storz EndoscopyAmerica Inc
2151 E Grand Ave
El Segundo,  CA  90245 -5017
Applicant Contact Leigh Spotten
Correspondent
Toscano Consulting
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact David Furr
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/13/2020
Decision Date 02/25/2021
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
Recalls CDRH Recalls
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