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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Processing Device For Estimation Of External Blood Loss
510(k) Number K232250
Device Name SurgiCount+ System
Applicant
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Patti Arndt
Correspondent
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Patti Arndt
Regulation Number880.2750
Classification Product Code
PBZ  
Date Received07/28/2023
Decision Date 01/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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