CONDOM

Condom

GLNIC CORP.

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

Pre-market Notification Details

• Device ID: K881100
• 510k Number: K881100
• Device Name: CONDOM
• Classification: Condom
• Applicant: GLNIC CORP. WORLD TRADE CENTER 350 SOUTH FIGUEROA ST. #509 Los Angeles, CA 90071
• Contact: Christine Uong
• Correspondent: Christine Uong; GLNIC CORP. WORLD TRADE CENTER 350 SOUTH FIGUEROA ST. #509 Los Angeles, CA 90071
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-03-15
• Decision Date: 1988-07-08