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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Infusion
510(k) Number K925066
Device Name PNEUMATIC IRRIGATION STANDARD
Applicant
Arthrodyn, Inc.
1422 W. Skyline Dr.
Madison,  WI  53705
Applicant Contact DAVID H BARTLETT
Correspondent
Arthrodyn, Inc.
1422 W. Skyline Dr.
Madison,  WI  53705
Correspondent Contact DAVID H BARTLETT
Regulation Number880.6990
Classification Product Code
FOX  
Date Received10/06/1992
Decision Date 07/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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