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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 K161195
Device Name Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
Applicant
M3 GLOBAL ENTERPRISES, LLC
70 BIRCH ALLEY, SUITE 240 BUILDING B
BEAVERCREEK,  OH  45440
Applicant Contact NEIL MEHTA
Correspondent
REGISTRAR CORP
144 RESEARCH DRIVE
HAMPTON,  VA  23666
Correspondent Contact Lara Luzak
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/27/2016
Decision Date 08/25/2016
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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