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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K170955
Device Name Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
1500 NE Hemlock
Redmond,  OR  97756
Applicant Contact Brandi Panteleon
Correspondent
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
1500 NE Hemlock
Redmond,  OR  97756
Correspondent Contact Brandi Panteleon
Classification Product Code
NLQ  
Date Received03/31/2017
Decision Date 07/03/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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