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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 K983320
Device Name ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
Applicant
Suretex Prophylactics (India) , Ltd.
74-91 Kiadb Industrial Estate
Jigani Ii Phase,Anekal Taluk
Bangalore, Karnataka,  IN 562106
Applicant Contact V.V. RAMANA RAO
Correspondent
Suretex Prophylactics (India) , Ltd.
74-91 Kiadb Industrial Estate
Jigani Ii Phase,Anekal Taluk
Bangalore, Karnataka,  IN 562106
Correspondent Contact V.V. RAMANA RAO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/21/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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