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, Synthetic
510(k) Number K203541
Device Name Okamoto 002 Lubricated Polyurethane Male Condom
Applicant
Okamoto USA, Inc.
18 King St.
Stratford,  CT  06615
Applicant Contact Yu Tadano
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Jeff N. Gibbs
Regulation Number884.5300
Classification Product Code
MOL  
Date Received12/03/2020
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-