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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 K002764
Device Name HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
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 Number888.1100
Classification Product Code
HRX  
Date Received09/05/2000
Decision Date 11/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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