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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K900674
Device Name CONSTI-SSAGE VIBRATOR/MASSAGE
Applicant
Bio-Tech Co.
Box 121 Rt 3
Washington,  IA  52353
Applicant Contact VICTOR J WEDEL
Correspondent
Bio-Tech Co.
Box 121 Rt 3
Washington,  IA  52353
Correspondent Contact VICTOR J WEDEL
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/13/1990
Decision Date 03/02/1990
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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