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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 K980920
Device Name EQUINOXE
Applicant
Bouvier Hydro, Inc.
100 Walnut St. Suite 20
P.O. Box 2874
Champlain,,  NY  12919
Applicant Contact ALAIN JOUAN
Correspondent
Bouvier Hydro, Inc.
100 Walnut St. Suite 20
P.O. Box 2874
Champlain,,  NY  12919
Correspondent Contact ALAIN JOUAN
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received03/10/1998
Decision Date 07/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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