Cleared Traditional

K780724 - BUBBLE SUCTION TUBING (FDA 510(k) Clearance)

Jun 1978
Decision
30d
Days
Class 2
Risk

K780724 is an FDA 510(k) clearance for the BUBBLE SUCTION TUBING. This device is classified as a Tube, Aspirating, Flexible, Connecting (Class II - Special Controls, product code BYY).

Submitted by Davol, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1978, 30 days after receiving the submission on May 3, 1978.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K780724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1978
Decision Date June 02, 1978
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code BYY — Tube, Aspirating, Flexible, Connecting
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6740