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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Non-Measuring
510(k) Number K851065
Device Name GRAVITY KING (DEEMED SE 87/09/18)
Applicant
Unique Functional Products
135 Sunshine Ln.
San Marcos,  CA  92069
Applicant Contact TIMOTHY B TUCKER
Correspondent
Unique Functional Products
135 Sunshine Ln.
San Marcos,  CA  92069
Correspondent Contact TIMOTHY B TUCKER
Regulation Number890.5370
Classification Product Code
ION  
Date Received03/15/1985
Decision Date 06/13/1985
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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