INVIGRA

Condom

INDUS MEDICARE LTD.

The following data is part of a premarket notification filed by Indus Medicare Ltd. with the FDA for Invigra.

Pre-market Notification Details

• Device ID: K020223
• 510k Number: K020223
• Device Name: INVIGRA
• Classification: Condom
• Applicant: INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh, IN 500 016
• Contact: P. K Reddy
• Correspondent: P. K Reddy; INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh, IN 500 016
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-01-22
• Decision Date: 2002-03-04