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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
Applicant
Pamco Distributing, Inc.
231 Arnold St.
Kitchener,  CA N2H 6E8
Applicant Contact Annette Maclean
Correspondent
Ironstone Product Development
250 Carlaw Ave., Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Catriona Boyd
Regulation Number884.5300
Classification Product Code
MSC  
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
Predetermined Change
Control Plan Authorized		 No
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