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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Exercise
510(k) Number K771030
Device Name FLEXION MITTENS
Applicant
Stat Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stat Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5350
Classification Product Code
IOD  
Date Received06/09/1977
Decision Date 06/27/1977
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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