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 K252622
Device Name Male Latex Condom HA
Applicant
Okamoto USA, Inc.
3130 W. Monroe St.
Sandusky,  OH  44870
Applicant Contact Kenji Komatsu
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Jeff Gibbs
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/19/2025
Decision Date 05/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-