Cleared Traditional

ISOLATION GOWN

K874888 · Sage Products, Inc. · General Hospital
Dec 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K874888 is an FDA 510(k) clearance for the ISOLATION GOWN, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Sage Products, Inc. (Cary, US). The FDA issued a Cleared decision on December 30, 1987, 29 days after receiving the submission on December 1, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K874888 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1987
Decision Date December 30, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FYC — Gown, Isolation, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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