Cleared Traditional

THE EXPANDACELL SINUS PACK

K935724 · Denver Splint Co. · Ear, Nose, Throat

May 1994

Decision

162d

Days

Class 1

Risk

About This 510(k) Submission

K935724 is an FDA 510(k) clearance for the THE EXPANDACELL SINUS PACK, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Denver Splint Co. (Englewood, US). The FDA issued a Cleared decision on May 12, 1994, 162 days after receiving the submission on December 1, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number	K935724 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 1993
Decision Date	May 12, 1994
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF