EZ SPRAY

Nebulizer, Medicinal, Non-ventilatory (atomizer)

INTERTEX RESEARCH, INC.

The following data is part of a premarket notification filed by Intertex Research, Inc. with the FDA for Ez Spray.

Pre-market Notification Details

• Device ID: K972397
• 510k Number: K972397
• Device Name: EZ SPRAY
• Classification: Nebulizer, Medicinal, Non-ventilatory (atomizer)
• Applicant: INTERTEX RESEARCH, INC. 2003 CASTLEROCK P.O. BOX 90785 Houston, TX 77090
• Contact: John Bullock
• Correspondent: John Bullock; INTERTEX RESEARCH, INC. 2003 CASTLEROCK P.O. BOX 90785 Houston, TX 77090
• Product Code: CCQ
• CFR Regulation Number: 868.5640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-26
• Decision Date: 1997-09-23
• Summary: summary