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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 K993872
Device Name VANNA BATHING SYSTEM
Applicant
Vancare, Inc.
1515 1st St.
Aurora,  NE  68818
Applicant Contact JAMES A VANDERHEIDEN
Correspondent
Vancare, Inc.
1515 1st St.
Aurora,  NE  68818
Correspondent Contact JAMES A VANDERHEIDEN
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received11/15/1999
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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