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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 K220791
Device Name Surgical and Prosthetic Trays
Applicant
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Courtney Clark
Correspondent
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Courtney Clark
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/18/2022
Decision Date 05/03/2022
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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