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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Spine Curvature
510(k) Number K081540
Device Name ZEGRA POSTURE TRAINER
Applicant
Peter Fischer
Christophstr. 2
Tubingen,  DE D72072
Applicant Contact PETER FISCHER
Correspondent
Peter Fischer
Christophstr. 2
Tubingen,  DE D72072
Correspondent Contact PETER FISCHER
Classification Product Code
LZW  
Date Received06/02/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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