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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 Drive, 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
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