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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
510(k) Number K180451
Device Name Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
Applicant
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Applicant Contact Scott English
Correspondent
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Correspondent Contact Scott English
Regulation Number878.4400
Classification Product Code
NUJ  
Subsequent Product Code
GEI  
Date Received02/20/2018
Decision Date 04/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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