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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 K912822
Device Name PERSONAL BODY MASSAGER, MODELS 1605 & 1606
Applicant
Raymond Industrial, Ltd.
121 Main St.
Norwalk,  CT  06851
Applicant Contact ROBERT B GANGNATH
Correspondent
Raymond Industrial, Ltd.
121 Main St.
Norwalk,  CT  06851
Correspondent Contact ROBERT B GANGNATH
Regulation Number890.5660
Classification Product Code
ISA  
Date Received06/25/1991
Decision Date 02/11/1992
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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