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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 K945257
Device Name 577ES (ERGOSENSE)
Applicant
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Applicant Contact JOSEPH MUELLER
Correspondent
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706
Correspondent Contact JOSEPH MUELLER
Regulation Number890.3110
Classification Product Code
INO  
Date Received10/28/1994
Decision Date 04/26/1995
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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