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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Board, Lap, Wheelchair
510(k) Number K772401
Device Name LAP BOARD W/RIM
Applicant
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fred Sammons, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3910
Classification Product Code
IMX  
Date Received12/27/1977
Decision Date 01/05/1978
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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