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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Heating, Powered
510(k) Number K880644
Device Name ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
Applicant
Fred Sammons, Inc.
145 Tower Dr.
Burr Ridge,  IL  60521
Applicant Contact SUSAN BLEDSOE
Correspondent
Fred Sammons, Inc.
145 Tower Dr.
Burr Ridge,  IL  60521
Correspondent Contact SUSAN BLEDSOE
Regulation Number890.5950
Classification Product Code
IRQ  
Date Received02/16/1988
Decision Date 05/06/1988
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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