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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 K954964
Device Name AQUACENTER 2000 SYSTEM
Applicant
Aquarius Medical Corp.
16 Technology Dr.
Suite 109
Irvine,  CA  92718
Applicant Contact JEFF CHANDLER
Correspondent
Aquarius Medical Corp.
16 Technology Dr.
Suite 109
Irvine,  CA  92718
Correspondent Contact JEFF CHANDLER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/30/1995
Decision Date 12/28/1995
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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