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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name exerciser, measuring
510(k) Number K890401
Device Name GOLDEN MEAN MACHINE(TM) (CLASS 2)
Applicant
BENNETT ERGONOMIC LABS, INC.
12305 62ND ST. NORTH, SUITE B
LARGO,  FL  34643 -3716
Applicant Contact JOHN F BENNETT
Correspondent
BENNETT ERGONOMIC LABS, INC.
12305 62ND ST. NORTH, SUITE B
LARGO,  FL  34643 -3716
Correspondent Contact JOHN F BENNETT
Regulation Number890.5360
Classification Product Code
ISD  
Date Received01/24/1989
Decision Date 04/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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