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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 K011612
Device Name MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
Applicant
Hydrocision, Inc.
7 Tiffany Trl.
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Hydrocision, Inc.
7 Tiffany Trl.
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number880.5475
Classification Product Code
FQH  
Date Received05/25/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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