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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom, synthetic
510(k) Number K203541
Device Name Okamoto 002 Lubricated Polyurethane Male Condom
Applicant
Okamoto U.S.A. Inc.
18 King Street
Stratford,  CT  06615
Applicant Contact Yu Tadano
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street 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
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