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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 K090848
Device Name PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
Applicant
PREMIER BRANDS OF AMERICA, INC.
120 PEARL ST.
MOUNT VERNON,  NY  10550
Applicant Contact MACK CAUTHEN
Correspondent
PREMIER BRANDS OF AMERICA, INC.
120 PEARL ST.
MOUNT VERNON,  NY  10550
Correspondent Contact MACK CAUTHEN
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received03/30/2009
Decision Date 06/17/2009
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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