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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 K940582
Device Name MASSAGING HELMET C.F. HANSEN DESIGN
Applicant
Philco Ushuaia
4881 Yonge St., Suite 602
North York, Ontario M2n 5x3
Canada,  CA
Applicant Contact ROBERTO RIVELA
Correspondent
Philco Ushuaia
4881 Yonge St., Suite 602
North York, Ontario M2n 5x3
Canada,  CA
Correspondent Contact ROBERTO RIVELA
Regulation Number890.5975
Classification Product Code
IRO  
Date Received02/08/1994
Decision Date 01/30/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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