Cleared Traditional

K760899 - STERILE DISPOSABLE COTTON PLUGGED SER. (FDA 510(k) Clearance)

Nov 1976
Decision
14d
Days
Class 1
Risk

K760899 is an FDA 510(k) clearance for the STERILE DISPOSABLE COTTON PLUGGED SER.. This device is classified as a Pipette, Pasteur (Class I - General Controls, product code GJW).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 9, 1976, 14 days after receiving the submission on October 26, 1976.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.6160.

Submission Details

510(k) Number K760899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1976
Decision Date November 09, 1976
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary

Device Classification

Product Code GJW — Pipette, Pasteur
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.6160