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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 K915361
Device Name THE BODY BUGGY
Applicant
Innova Corp.
80 Park St.
Montclair,  NJ  07042
Applicant Contact JOHN SULLIVAN
Correspondent
Innova Corp.
80 Park St.
Montclair,  NJ  07042
Correspondent Contact JOHN SULLIVAN
Regulation Number890.5660
Classification Product Code
LYG  
Date Received11/27/1991
Decision Date 12/20/1991
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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