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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 K905599
Device Name JETTA JR. HYDRO MASSAGE
Applicant
Jetta Products, Inc.
500-A Centennial Blvd.
Edmond,  OK  73013
Applicant Contact BILL WOLF
Correspondent
Jetta Products, Inc.
500-A Centennial Blvd.
Edmond,  OK  73013
Correspondent Contact BILL WOLF
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received12/13/1990
Decision Date 03/26/1991
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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