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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 K161693
Device Name Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
Applicant
STRYKER SUSTAINABILITY SOLUTIONS
1810 W. Drake Dr.
Tempe,  AZ  85283
Applicant Contact Scott English
Correspondent
STRYKER SUSTAINABILITY SOLUTIONS
1810 W. Drake Dr.
Tempe,  AZ  85283
Correspondent Contact Scott English
Classification Product Code
NLQ  
Subsequent Product Code
LFL  
Date Received06/20/2016
Decision Date 02/23/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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