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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
510(k) Number K220481
Device Name Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
Applicant
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Applicant Contact Scott English
Correspondent
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Correspondent Contact Scott English
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/18/2022
Decision Date 05/25/2022
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
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