TRUST

Nebulizer (direct Patient Interface)

DHD HEALTHCARE CORP.

The following data is part of a premarket notification filed by Dhd Healthcare Corp. with the FDA for Trust.

Pre-market Notification Details

• Device ID: K040718
• 510k Number: K040718
• Device Name: TRUST
• Classification: Nebulizer (direct Patient Interface)
• Applicant: DHD HEALTHCARE CORP. ONE MADISON ST. Wampsville, NY 13163
• Contact: David Geary
• Correspondent: Robert Mosenkis; CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-03-19
• Decision Date: 2004-04-02
• Summary: summary