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 with nonoxynol-9
510(k) Number K012969
Device Name DOUBLE SPRINGERS NONOXNOL 9 CONDOM
Applicant
MEDTECH PRODUCTS LTD.
S-59 20TH ST., ANNA NAGAR WEST
CHENNAI,  IN 600 040
Applicant Contact A. V. K. REDDY
Correspondent
MEDTECH PRODUCTS LTD.
S-59 20TH ST., ANNA NAGAR WEST
CHENNAI,  IN 600 040
Correspondent Contact A. V. K. REDDY
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received09/04/2001
Decision Date 06/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-