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: K991374
• 510k Number: K991374
• 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: 1999-04-21
• Decision Date: 1999-06-15