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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 K221074
Device Name OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
Applicant
Stryker Corporation
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Bruce Backlund
Correspondent
Stryker Corporation
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Bruce Backlund
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/12/2022
Decision Date 09/16/2022
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
Predetermined Change
Control Plan Authorized		 No
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