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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 K021813
Device Name HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
Applicant
Hydrocision, Inc.
7 Tiffany Trail
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Hydrocision, Inc.
7 Tiffany Trail
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number880.5475
Classification Product Code
FQH  
Date Received06/03/2002
Decision Date 05/09/2003
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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