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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 K203536
Device Name Male Latex Condom
Applicant
Global Protection Corp.
12 Channel Street
Boston,  MA  02210
Applicant Contact Christina Cataldo
Correspondent
Global Protection Corp.
12 Channel Street
Boston,  MA  02210
Correspondent Contact Christina Cataldo
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/03/2020
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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