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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 K002876
Device Name JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
Applicant
Suiter Medical LLC
203 W. 2nd St.
Mc Cook,  NE  69001
Applicant Contact JAMES P SUITER
Correspondent
Suiter Medical LLC
203 W. 2nd St.
Mc Cook,  NE  69001
Correspondent Contact JAMES P SUITER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/14/2000
Decision Date 10/11/2000
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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