Cleared Traditional

INTERA SHIELD AND INTERA UNDERGARMENT

K885185 · Intera Corp. · Gastroenterology & Urology
Feb 1989
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K885185 is an FDA 510(k) clearance for the INTERA SHIELD AND INTERA UNDERGARMENT, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Intera Corp. (Chattanooga, US). The FDA issued a Cleared decision on February 8, 1989, 56 days after receiving the submission on December 14, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K885185 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1988
Decision Date February 08, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EYQ — Garment, Protective, For Incontinence
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5920

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