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 K884469
Device Name ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS
Applicant
MAYER LABORATORIES
1611 TELEGRAPH AVENUE, SUITE
830
OAKLAND,  CA  94612
Applicant Contact DAVID P MAYER
Correspondent
MAYER LABORATORIES
1611 TELEGRAPH AVENUE, SUITE
830
OAKLAND,  CA  94612
Correspondent Contact DAVID P MAYER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/25/1988
Decision Date 03/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-