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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K925193
Device Name AQUACISER II
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 Number890.5100
Classification Product Code
ILJ  
Subsequent Product Code
BXB  
Date Received10/15/1992
Decision Date 08/26/1994
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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