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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 K922603
Device Name TOTAL WORK INTEGRATOR, MODEL #940-110
Applicant
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number890.5360
Classification Product Code
ISD  
Date Received06/02/1992
Decision Date 06/19/1992
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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