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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K151101
Device Name Lotus Series 4 Ultrasonic Surgical System & Accessories
Applicant
Sra Developments, Ltd.
Bremridge House
Ashburton, Devon,  GB TQ13 7JX
Applicant Contact Alan Chivers
Correspondent
Sra Developments, Ltd.
Bremridge House
Ashburton, Devon,  GB TQ13 7JX
Correspondent Contact Alan Chivers
Classification Product Code
LFL  
Date Received04/24/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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