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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 K853163
Device Name SETMA VHT
Applicant
Setma, Inc.
Whitehouse,  NJ  08888
Applicant Contact RICHARD B DARDAS
Correspondent
Setma, Inc.
Whitehouse,  NJ  08888
Correspondent Contact RICHARD B DARDAS
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received07/30/1985
Decision Date 11/05/1985
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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