Cleared Traditional

BOARD, ARM (WITH COVER)

K864670 · Anago, Inc. · General & Plastic Surgery
Jan 1987
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K864670 is an FDA 510(k) clearance for the BOARD, ARM (WITH COVER), a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 12, 1987, 41 days after receiving the submission on December 2, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3910.

Submission Details

510(k) Number K864670 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1986
Decision Date January 12, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code BTX — Board, Arm (with Cover), Sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.3910

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