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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K950400
Device Name HAND MASSAGE UNIT
Applicant
Ultrassage, Inc.
5680 Rue Pare,
Ville Mont-Royal, Quebec,  CA H4P 2M2
Applicant Contact KEN KUPELIAN
Correspondent
Ultrassage, Inc.
5680 Rue Pare,
Ville Mont-Royal, Quebec,  CA H4P 2M2
Correspondent Contact KEN KUPELIAN
Regulation Number890.5975
Classification Product Code
IRO  
Date Received02/01/1995
Decision Date 03/30/1995
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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