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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tips And Pads, Cane, Crutch And Walker
510(k) Number K810650
Device Name CRUTCH TIPS & GRIPS
Applicant
First Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
First Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3790
Classification Product Code
INP  
Date Received03/10/1981
Decision Date 03/26/1981
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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