Cleared Traditional

K760382 - CONNECTORS
(FDA 510(k) Clearance)

Nov 1976
Decision
89d
Days
Class 1
Risk

K760382 is an FDA 510(k) clearance for the CONNECTORS. This device is classified as a Connector, Catheter (Class I - General Controls, product code GCD).

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 FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K760382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 GCD — Connector, Catheter
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4200