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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 K080506
Device Name MARTIN CHAIR, MODEL C4S1
Applicant
Martin Manufacturing Co., LLC
621-101 Hutton St.
Raleigh,  NC  27606
Applicant Contact MICHAEL ZAPATA, III
Correspondent
Martin Manufacturing Co., LLC
621-101 Hutton St.
Raleigh,  NC  27606
Correspondent Contact MICHAEL ZAPATA, III
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
LGX  
Date Received02/25/2008
Decision Date 06/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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