Cleared Traditional

K910167 - MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
(FDA 510(k) Clearance)

K910167 · Microbio-Medics, Inc. · General & Plastic Surgery
Apr 1991
Decision
90d
Days
Class 1
Risk

K910167 is an FDA 510(k) clearance for the MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Microbio-Medics, Inc. (Tucker, US). The FDA issued a Cleared decision on April 15, 1991, 90 days after receiving the submission on January 15, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.

Submission Details

510(k) Number K910167 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1991
Decision Date April 15, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4680

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