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 K865106
Device Name PROPHYLACTIC (CONDOM) MR. JOHNNY
Applicant
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Applicant Contact DOCAL, M.D.
Correspondent
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Correspondent Contact DOCAL, M.D.
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/31/1986
Decision Date 05/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-