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 K963321
Device Name OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
Applicant
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Applicant Contact LILLIE C THOMAS, M.S.
Correspondent
CUSTOM SERVICES INTL., INC.
3111 WEST POST RD.
LAS VEGAS,  NV  89118
Correspondent Contact LILLIE C THOMAS, M.S.
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/12/1996
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-