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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 K253445
Device Name BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
Applicant
Bd
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Dainel Ehrhardt
Correspondent
Bd
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Dainel Ehrhardt
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received10/02/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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