EMBRACE

Condom

SAFETEX CORP.

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

Pre-market Notification Details

• Device ID: K900359
• 510k Number: K900359
• Device Name: EMBRACE
• Classification: Condom
• Applicant: SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights, VA 23834
• Contact: Ronald L Davis
• Correspondent: Ronald L Davis; SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights, VA 23834
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-01-25
• Decision Date: 1990-04-02