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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 K190804
Device Name HydroCision TenJet Device
Applicant
Hydrocision, Inc.
267 Boston Rd.
Suite 28
North Billerica,  MA  01862
Applicant Contact Mark J. Lewis
Correspondent
Mae Consulting Group, LLC
119 N. Rd.
Deerfield,  NH  03037
Correspondent Contact Yashesh Rawal
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/29/2019
Decision Date 06/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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