PRIME

Condom

ANSELL, INC.

The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Prime.

Pre-market Notification Details

• Device ID: K830691
• 510k Number: K830691
• Device Name: PRIME
• Classification: Condom
• Applicant: ANSELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-01
• Decision Date: 1983-03-31