Cleared Traditional

STERI-SHIELD

K903533 · Biomedical Devices, Inc. · General Hospital
Oct 1990
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K903533 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 October 19, 1990, 74 days after receiving the submission on August 6, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K903533 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1990
Decision Date October 19, 1990
Days to Decision 74 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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