CASABLANCA

Condom

ARCON CORP.

The following data is part of a premarket notification filed by Arcon Corp. with the FDA for Casablanca.

Pre-market Notification Details

• Device ID: K841600
• 510k Number: K841600
• Device Name: CASABLANCA
• Classification: Condom
• Applicant: ARCON CORP. 1421 2ND. AVENUE NW. Stewartville, MN 55976
• Contact: Anthony J Conway
• Correspondent: Anthony J Conway; ARCON CORP. 1421 2ND. AVENUE NW. Stewartville, MN 55976
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-18
• Decision Date: 1984-11-29