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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 K192669
Device Name Extremely Thin 003, ZERO ZERO THREE
Applicant
Okamoto USA, Inc.
18 King St.
Stratford,  CT  06615
Applicant Contact Yu Tadano
Correspondent
Hyman, Phelps & McNamara, PC
Washington,  DC  20005
Correspondent Contact Jeffrey N. Gibbs
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/25/2019
Decision Date 07/24/2020
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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