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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K213824
Device Name Sonopet iQ Ultrasonic Aspirator System
Applicant
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact Thomas Flannelly
Correspondent
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact Thomas Flannelly
Classification Product Code
LFL  
Date Received12/08/2021
Decision Date 02/03/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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