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 K890407
Device Name THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
Applicant
CIRCLE RUBBER CORP.
408 FRELINGHUYSEN AVE.
P.O. BOX 223
NEWARK,  NJ  07114
Applicant Contact MITSUO SAITO
Correspondent
CIRCLE RUBBER CORP.
408 FRELINGHUYSEN AVE.
P.O. BOX 223
NEWARK,  NJ  07114
Correspondent Contact MITSUO SAITO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/24/1989
Decision Date 05/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-