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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 K874716
Device Name PULSOR, THERAPEUTIC VIBRATOR
Applicant
Gmg Enterprises, Inc.
P.O. Box 5274
Lake Wylie,  SC  29710
Applicant Contact GUENTER A GINSBERG
Correspondent
Gmg Enterprises, Inc.
P.O. Box 5274
Lake Wylie,  SC  29710
Correspondent Contact GUENTER A GINSBERG
Regulation Number890.5660
Classification Product Code
ISA  
Date Received11/17/1987
Decision Date 02/11/1988
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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