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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Positioning, Electric
510(k) Number K930262
Device Name TREATMENT TABLE, MODEL #825-100
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 Number890.3110
Classification Product Code
INO  
Date Received01/19/1993
Decision Date 03/29/1993
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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