• 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 K860909
Device Name WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)
Applicant
U. C. IMPORT & CO.
P.O. BOX 6161
beverly hills,  PA  90212
Applicant Contact max naami
Correspondent
U. C. IMPORT & CO.
P.O. BOX 6161
beverly hills,  PA  90212
Correspondent Contact max naami
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/10/1986
Decision Date 08/19/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-