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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K213616
Device Name BD Surgiphor Antimicrobial Irrigation System
Applicant
Becton, Dickinson and Company
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Shelley Wilcox
Correspondent
Becton, Dickinson and Company
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Shelley Wilcox
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received11/15/2021
Decision Date 03/23/2022
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 Yes
Predetermined Change
Control Plan Authorized		 No
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