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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 K894154
Device Name METABOLIC SYSTEMS
Applicant
CYBEX
2100 SMITHTOWN AVE.
P.O. BOX 9003
RONKONKOMA,  NY  11779
Applicant Contact WILLIAM SAUER
Correspondent
CYBEX
2100 SMITHTOWN AVE.
P.O. BOX 9003
RONKONKOMA,  NY  11779
Correspondent Contact WILLIAM SAUER
Regulation Number890.5360
Classification Product Code
ISD  
Date Received06/14/1989
Decision Date 10/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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