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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 K922606
Device Name MULTI JOINT WEIGHT SYSTEM MODEL #940-100
Applicant
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Applicant Contact CYLDE SCHLEIN
Correspondent
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Correspondent Contact CYLDE 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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