Cleared Traditional

K760389 - CANNULA, IV
(FDA 510(k) Clearance)

K760389 · B. Braun Instruments · General & Plastic Surgery
Nov 1976
Decision
89d
Days
Class 1
Risk

K760389 is an FDA 510(k) clearance for the CANNULA, IV, a Cannula, Injection (Class I — General Controls, product code FGY), submitted by B. Braun Instruments (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976, 89 days after receiving the submission on August 5, 1976. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K760389 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1976
Decision Date November 02, 1976
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FGY — Cannula, Injection
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200