Cleared Traditional

K915158 - SUREBREATH DOME, E-Z BREATHER (FDA 510(k) Clearance)

K915158 · Ipax, Inc. · General & Plastic Surgery device

Feb 1992

Decision

90d

Days

Class 1

Risk

K915158 is an FDA 510(k) clearance for the SUREBREATH DOME, E-Z BREATHER. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on February 12, 1992, 90 days after receiving the submission on November 14, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K915158 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 1991
Decision Date	February 12, 1992
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement