NAKED

Condom

VERAXIS INT'L INC.

The following data is part of a premarket notification filed by Veraxis Int'l Inc. with the FDA for Naked.

Pre-market Notification Details

• Device ID: K060797
• 510k Number: K060797
• Device Name: NAKED
• Classification: Condom
• Applicant: VERAXIS INT'L INC. 261 MADISON AVENUE 24TH FLOOR New York, NY 10016
• Contact: Jules T Mitchel
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-03-24
• Decision Date: 2006-04-07
• Summary: summary