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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 K864670
Device Name BOARD, ARM (WITH COVER)
Applicant
ANAGO, INC.
7524 MOSIER VIEW CT.
FORT WORTH,  TX  76118
Applicant Contact KATHY RUSSELL
Correspondent
ANAGO, INC.
7524 MOSIER VIEW CT.
FORT WORTH,  TX  76118
Correspondent Contact KATHY RUSSELL
Regulation Number878.3910
Classification Product Code
BTX  
Date Received12/02/1986
Decision Date 01/12/1987
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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