Cleared Abbreviated

K142034 - 3M STERI-VAC STERILIZER/AERATOR
(FDA 510(k) Clearance)

K142034 · 3M Company · General Hospital

Jan 2015

Decision

164d

Days

Class 2

Risk

K142034 is an FDA 510(k) clearance for the 3M STERI-VAC STERILIZER/AERATOR. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II — Special Controls, product code FLF).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 8, 2015, 164 days after receiving the submission on July 28, 2014.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number	K142034 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2014
Decision Date	January 08, 2015
Days to Decision	164 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF