PROMENADE

Nebulizer (direct Patient Interface)

MADA MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Mada Medical Products, Inc. with the FDA for Promenade.

Pre-market Notification Details

• Device ID: K930947
• 510k Number: K930947
• Device Name: PROMENADE
• Classification: Nebulizer (direct Patient Interface)
• Applicant: MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072
• Contact: Jeffrey W Adam
• Correspondent: Jeffrey W Adam; MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-23
• Decision Date: 1993-06-01