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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 K191522
Device Name Straumann Modular Cassette
Applicant
Institut Straumann AG
Peter Merian-Weg 12
Basal,  CH 4002
Applicant Contact Jenni Vescovo
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/10/2019
Decision Date 12/03/2019
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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