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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
Okamoto U.S.A., Inc.
18 King Street
Stratford,  CT  06615
Applicant Contact Yu Tadano
Hyman, Phelps & McNamara, P.C.
Washington,  DC  20005
Correspondent Contact Jeffrey N. Gibbs
Regulation Number884.5300
Classification Product Code
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