TRI-PLEX ADAPTER

Accessory To Continuous Ventilator (respirator)

THE MEDICAL DEVICE GROUP, INC.

The following data is part of a premarket notification filed by The Medical Device Group, Inc. with the FDA for Tri-plex Adapter.

Pre-market Notification Details

• Device ID: K010401
• 510k Number: K010401
• Device Name: TRI-PLEX ADAPTER
• Classification: Accessory To Continuous Ventilator (respirator)
• Applicant: THE MEDICAL DEVICE GROUP, INC. PO BOX 4341 Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; THE MEDICAL DEVICE GROUP, INC. PO BOX 4341 Crofton, MD 21114
• Product Code: MOD
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-12
• Decision Date: 2002-10-30