Cleared Traditional

STERI-SHIELD

K902677 · Biomedical Devices, Inc. · General Hospital
Aug 1990
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K902677 is an FDA 510(k) clearance for the STERI-SHIELD, a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Biomedical Devices, Inc. (Fullerton, US). The FDA issued a Cleared decision on August 17, 1990, 60 days after receiving the submission on June 18, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K902677 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1990
Decision Date August 17, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FXY — Hood, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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