TOP GUN

Lavage, Jet

BIO-MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Bio-medical Devices, Inc. with the FDA for Top Gun.

Pre-market Notification Details

• Device ID: K933742
• 510k Number: K933742
• Device Name: TOP GUN
• Classification: Lavage, Jet
• Applicant: BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614
• Contact: Nick Herbert
• Correspondent: Nick Herbert; BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614
• Product Code: FQH
• CFR Regulation Number: 880.5475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-08-03
• Decision Date: 1994-04-07