Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Condom
510(k) Number K000040
Device Name INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
Applicant
Indus Medicare , Ltd.
144, S.P. Rd., Begumpet
Hyderabad Andhra Pradesh,  IN 500 016
Applicant Contact P.K. REDDY
Correspondent
Indus Medicare , Ltd.
144, S.P. Rd., Begumpet
Hyderabad Andhra Pradesh,  IN 500 016
Correspondent Contact P.K. REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/06/2000
Decision Date 03/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-