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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, Manual
510(k) Number K936148
Device Name STRESS HANDLER
Applicant
Arocep Enterprises , Ltd.
80 English St.
Brampton, Ontario,  CA L6X 2P6
Applicant Contact C. G. PECORA
Correspondent
Arocep Enterprises , Ltd.
80 English St.
Brampton, Ontario,  CA L6X 2P6
Correspondent Contact C. G. PECORA
Regulation Number890.5660
Classification Product Code
LYG  
Date Received12/27/1993
Decision Date 04/21/1994
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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