VIVA

Condom

RICHTER RUBBER TECHNOLOGY SDN. BHD.

The following data is part of a premarket notification filed by Richter Rubber Technology Sdn. Bhd. with the FDA for Viva.

Pre-market Notification Details

• Device ID: K011480
• 510k Number: K011480
• Device Name: VIVA
• Classification: Condom
• Applicant: RICHTER RUBBER TECHNOLOGY SDN. BHD. BOX 32222 Louisville, KY 40232
• Contact: Frank C Sadlo
• Correspondent: Frank C Sadlo; RICHTER RUBBER TECHNOLOGY SDN. BHD. BOX 32222 Louisville, KY 40232
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-14
• Decision Date: 2001-05-24