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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K935011
Device Name SWIMEX MULTIDEPTH POOL (MODEL 600T)
Applicant
Swimex Systems
P.O. Box 328
Warren,  RI  02885
Applicant Contact CHRISTOPHER W FADDEN
Correspondent
Swimex Systems
P.O. Box 328
Warren,  RI  02885
Correspondent Contact CHRISTOPHER W FADDEN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/20/1993
Decision Date 01/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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