SWABCAP

Cap, Device Disinfectant

EXCELSIOR MEDICAL CORP.

The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Swabcap.

Pre-market Notification Details

• Device ID: K083508
• 510k Number: K083508
• Device Name: SWABCAP
• Classification: Cap, Device Disinfectant
• Applicant: EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On, CA L2h 7p3
• Contact: Roshana Ahmed
• Correspondent: Roshana Ahmed; EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On, CA L2h 7p3
• Product Code: QBP
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-26
• Decision Date: 2009-04-28
• Summary: summary