BREATHE FIT

Dilator, Nasal

CAMBRIDGE ASSOC.

The following data is part of a premarket notification filed by Cambridge Assoc. with the FDA for Breathe Fit.

Pre-market Notification Details

• Device ID: K963326
• 510k Number: K963326
• Device Name: BREATHE FIT
• Classification: Dilator, Nasal
• Applicant: CAMBRIDGE ASSOC. 15 OAK ST. Beverly Farms, MA 01915
• Contact: Fran White
• Correspondent: Fran White; CAMBRIDGE ASSOC. 15 OAK ST. Beverly Farms, MA 01915
• Product Code: LWF
• CFR Regulation Number: 874.3900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-23
• Decision Date: 1997-02-12
• Summary: summary