The following data is part of a premarket notification filed by Indus Medicare Ltd. with the FDA for Invigra.
Device ID | K022614 |
510k Number | K022614 |
Device Name: | INVIGRA |
Classification | Condom |
Applicant | INDUS MEDICARE LTD. 144, S.P. RD., BEGUMPET Hyderabad Andhra Pradesh, IN 500 016 |
Contact | P. Janardhan Reddy |
Correspondent | P. Janardhan 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 | 2002-08-06 |
Decision Date | 2003-04-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INVIGRA 75524407 not registered Dead/Abandoned |
SAYAGE, LARRY 1998-07-23 |
INVIGRA 75510340 not registered Dead/Abandoned |
GeneRx, Inc. 1998-06-29 |