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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 K952041
Device Name BODYFLEX MASSAGER
Applicant
Truro'S Ent.
760 Dalgliesh Dr.
Egina, Saskatchewan,  CA S4R 6G2
Applicant Contact DEREK PARNELL
Correspondent
Truro'S Ent.
760 Dalgliesh Dr.
Egina, Saskatchewan,  CA S4R 6G2
Correspondent Contact DEREK PARNELL
Regulation Number890.5660
Classification Product Code
ISA  
Date Received05/01/1995
Decision Date 08/14/1995
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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