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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 K032529
Device Name HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310
Applicant
HYDROCISION, INC.
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
HYDROCISION, INC.
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/15/2003
Decision Date 09/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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