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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 K060782
Device Name VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
Applicant
Smith & Nephew Wound Management
11775 Starkey Rd.
Largo,  FL  33773
Applicant Contact TERRY MCMAHON
Correspondent
Smith & Nephew Wound Management
11775 Starkey Rd.
Largo,  FL  33773
Correspondent Contact TERRY MCMAHON
Regulation Number880.5475
Classification Product Code
FQH  
Date Received03/22/2006
Decision Date 04/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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