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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 K925807
Device Name AQUACISER IN-POOL TREADMILL
Applicant
Aquaciser, Inc.
201 Gore Creek Rd.
Vail,  CO  81657
Applicant Contact THOMAS H HOPKINS
Correspondent
Aquaciser, Inc.
201 Gore Creek Rd.
Vail,  CO  81657
Correspondent Contact THOMAS H HOPKINS
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/16/1992
Decision Date 03/24/1993
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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