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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 K974323
Device Name LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
Applicant
REDDY MEDTECH HEALTH PRODUCTS LTD.
9 WEBSTER COURT
PLAINSBORO,  NJ  08536
Applicant Contact RAVI REDDY
Correspondent
REDDY MEDTECH HEALTH PRODUCTS LTD.
9 WEBSTER COURT
PLAINSBORO,  NJ  08536
Correspondent Contact RAVI REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/18/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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