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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 K922602
Device Name CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
Applicant
BIODAN MEDICAL SYSTEMS, LTD.
BROOKHAVE R & D PLAZA
20 RAMSAY RD.,BOX 702
SHIRLEY,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
BIODAN MEDICAL SYSTEMS, LTD.
BROOKHAVE R & D PLAZA
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
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