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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K941157
Device Name BASIC RECLINE CHAIR
Applicant
Labac Systems, Inc.
8955 S. Ridgeline
Boulevard
Highlands Ranch,  CO  80126
Applicant Contact PETER ZEEB
Correspondent
Labac Systems, Inc.
8955 S. Ridgeline
Boulevard
Highlands Ranch,  CO  80126
Correspondent Contact PETER ZEEB
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/11/1994
Decision Date 04/07/1994
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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