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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 K172414
Device Name JUD custom fit condom
Applicant
Global Mailer Partners, LLC
50 South Pointe Drive
Miami Beach,  FL  33139
Applicant Contact Jud Ireland
Correspondent
Target Health Inc.
261 Madison Avenue, 24th Floor
New York,  NY  10016
Correspondent Contact Adam Harris
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/10/2017
Decision Date 10/12/2017
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
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