OASIS

Condom

GLIMEX CORP.

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

Pre-market Notification Details

• Device ID: K984218
• 510k Number: K984218
• Device Name: OASIS
• Classification: Condom
• Applicant: GLIMEX CORP. 705-2 EAST BIDWELL ST., #131 Folsom, CA 95630
• Contact: Jeff Hackett
• Correspondent: Jeff Hackett; GLIMEX CORP. 705-2 EAST BIDWELL ST., #131 Folsom, CA 95630
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-24
• Decision Date: 1998-12-17