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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, std, oral sex
510(k) Number K203727
Device Name Harmony Latex Dam, Harmony Non-Latex Dam
Pamco Distributing Inc.
231 Arnold Street
Kitchener,  CA N2H 6E8
Applicant Contact Annette Maclean
Ironstone Product Development
250 Carlaw Avenue, Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Catriona Boyd
Regulation Number884.5300
Classification Product Code
Date Received12/21/2020
Decision Date 08/05/2021
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