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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 K151405
Device Name Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
Applicant
Surgical Instrument Services and Savings(Dba Medline Renewal
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact Brandi Panteleon
Correspondent
Surgical Instrument Services and Savings(Dba Medline Renewal
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact Brandi Panteleon
Classification Product Code
NLQ  
Date Received05/26/2015
Decision Date 01/26/2016
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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