BOARD, ARM (WITH COVER)

Board, Arm (with Cover), Sterile

ANAGO, INC.

The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Board, Arm (with Cover).

Pre-market Notification Details

Device IDK864670
510k NumberK864670
Device Name:BOARD, ARM (WITH COVER)
ClassificationBoard, Arm (with Cover), Sterile
Applicant ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth,  TX  76118
ContactKathy Russell
CorrespondentKathy Russell
ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth,  TX  76118
Product CodeBTX  
CFR Regulation Number878.3910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-02
Decision Date1987-01-12

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