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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 K930624
Device Name SANITAS WHIRPOOL BATHING SYSTEM
Applicant
Dutton-Lainson Co.
451 W. Second St.
Hastings,  NE  68902
Applicant Contact RON HAASE
Correspondent
Dutton-Lainson Co.
451 W. Second St.
Hastings,  NE  68902
Correspondent Contact RON HAASE
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received02/08/1993
Decision Date 07/01/1994
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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