Cleared Traditional

SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES

K930512 · Core Dynamics, Inc. · General Hospital
Jul 1993
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K930512 is an FDA 510(k) clearance for the SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES, a Tubing, Noninvasive (Class II — Special Controls, product code GAZ), submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 23, 1993, 172 days after receiving the submission on February 1, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K930512 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1993
Decision Date July 23, 1993
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code GAZ — Tubing, Noninvasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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