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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 K982266
Device Name HYDROCISION ARTHROJET SYSTEM
Applicant
Hydrocision, Inc.
220 Ballardvale St.
Wilmington,  MA  01887
Applicant Contact ERIC BANNON
Correspondent
Hydrocision, Inc.
220 Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact ERIC BANNON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/29/1998
Decision Date 09/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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