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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K020688
Device Name HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
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 Number888.1100
Classification Product Code
HRX  
Date Received03/04/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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