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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K243584
Device Name 0.04 ZERO ZERO FOUR Male Latex Condom
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 Received11/20/2024
Decision Date 02/18/2025
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
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