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 K871036
Device Name CONDOM TAKASO RUBBER PRODUCTS SDN/BDH
Applicant
TAKASO RUBBER C/O INTERSTATE SUPPLIER, INC.
7135 HOLLYWOOD BLVD. #509
LOS ANGELES,  CA  90046
Applicant Contact DOUGLAS LIN
Correspondent
TAKASO RUBBER C/O INTERSTATE SUPPLIER, INC.
7135 HOLLYWOOD BLVD. #509
LOS ANGELES,  CA  90046
Correspondent Contact DOUGLAS LIN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/17/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-