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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K923365
Device Name TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM
Applicant
Labsystems, Inc.
8955 S. Ridgeline Blvd.
Unit A
Highlands Ranch,  CO  80126
Applicant Contact PETER ZEEB
Correspondent
Labsystems, Inc.
8955 S. Ridgeline Blvd.
Unit A
Highlands Ranch,  CO  80126
Correspondent Contact PETER ZEEB
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/08/1992
Decision Date 03/24/1993
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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