Cleared Traditional

K790929 - DRAINAGE BAG
(FDA 510(k) Clearance)

K790929 · Mem Medical, Inc. · Anesthesiology
May 1979
Decision
6d
Days
Class 1
Risk

K790929 is an FDA 510(k) clearance for the DRAINAGE BAG. This device is classified as a Drain, Tee (water Trap) (Class I — General Controls, product code BYH).

Submitted by Mem Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1979, 6 days after receiving the submission on May 15, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K790929 FDA.gov
FDA Decision Cleared Substantially Equivalent — Traditional 510(k) (SESE)
Date Received May 15, 1979
Decision Date May 21, 1979
Days to Decision 6 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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