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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 K131866
Device Name SUSTAIN
Applicant
HOLLENDER SUSTAINABLE BRANDS LLC
1468 HARWELL AVE
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
HOLLENDER SUSTAINABLE BRANDS LLC
1468 HARWELL AVE
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/24/2013
Decision Date 05/01/2014
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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