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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name board, arm (with cover), sterile
510(k) Number K781233
Device Name IV ARMBOARDS
Applicant
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FIBRE FORMATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3910
Classification Product Code
BTX  
Date Received07/19/1978
Decision Date 08/14/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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