Cleared Traditional

THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM

K897057 · Thayer Medical Corp. · Anesthesiology
Mar 1990
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K897057 is an FDA 510(k) clearance for the THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM, a Drain, Tee (water Trap) (Class I — General Controls, product code BYH), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on March 16, 1990, 88 days after receiving the submission on December 18, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K897057 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYH — Drain, Tee (water Trap)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5995

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