STERI-SHIELD

Hood, Surgical

BIOMEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Biomedical Devices, Inc. with the FDA for Steri-shield.

Pre-market Notification Details

• Device ID: K903533
• 510k Number: K903533
• Device Name: STERI-SHIELD
• Classification: Hood, Surgical
• Applicant: BIOMEDICAL DEVICES, INC. 1501 E. CHAPMAN, SUITE 356 Fullerton, CA 92631
• Contact: Nick Herbert
• Correspondent: Nick Herbert; BIOMEDICAL DEVICES, INC. 1501 E. CHAPMAN, SUITE 356 Fullerton, CA 92631
• Product Code: FXY
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-08-06
• Decision Date: 1990-10-19