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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 K884907
Device Name BUMPY MEDICAL MASSAGE MAT
Applicant
Medical Flotation Systems, Inc.
104 Elden St., Suite 11
Herndon,  VA  22070
Applicant Contact JACOBS, MD
Correspondent
Medical Flotation Systems, Inc.
104 Elden St., Suite 11
Herndon,  VA  22070
Correspondent Contact JACOBS, MD
Regulation Number890.5660
Classification Product Code
LYG  
Date Received11/23/1988
Decision Date 12/27/1988
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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