Cleared Traditional

NON-STERILE ISOLATION GOWN

K931145 · Amsco Sterile Recoveries, Inc. · General Hospital
Jun 1994
Decision
462d
Days
Class 2
Risk

About This 510(k) Submission

K931145 is an FDA 510(k) clearance for the NON-STERILE ISOLATION GOWN, a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 10, 1994, 462 days after receiving the submission on March 5, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K931145 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1993
Decision Date June 10, 1994
Days to Decision 462 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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