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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 K201067
Device Name CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
Applicant
Cupid Limited
A-68, M.I.D.C. (Malegaon), Sinnar
Nashik,  IN 422113
Applicant Contact Durgesh Garg
Correspondent
Liberty Management Group , Ltd.
75 Executive Dr., Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/22/2020
Decision Date 08/07/2020
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
Predetermined Change
Control Plan Authorized		 No
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