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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 K170456
Device Name Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Applicant
Stryker Sustainability Solutions
1810 W Dr.ake Dr.
Tempe,  AZ  85283
Applicant Contact Chelsea Cullen
Correspondent
Stryker Sustainability Solutions
1810 W Dr.ake Dr.
Tempe,  AZ  85283
Correspondent Contact Chelsea Cullen
Classification Product Code
NLQ  
Date Received02/15/2017
Decision Date 04/05/2017
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
Recalls CDRH Recalls
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